01 - LSU Health Sciences Center New Orleans
Louisiana State University Health Sciences Center
Stanley S. Scott Cancer Center
Minority- Based CCOP
Research Protocol List
Last Updated: 03/23/2011
CLINICAL TRIALS CONTACTS
LSU-NEW ORLEANS
Investigators
Anthony, Lowell……………………………..504-464-8500
Lin, Tara………………………………………504-568-5151
Boulmay, Brian……………………………...504-568-5151
Fuselier, Harold (Urology) ………………...504-412-1620
Nurses
Edwards, Cindy ……………………………..504-568-3430
Nunez, Julie………………………………… 504-568-3435
Regulatory
Johnson, Cara………………………………..504-568-3410
ROBERT W. VEITH, LLC
Veith, Robert………………………………….504-455-0600
Nurse
Nunez, Julie…………………………………...504-568-3435
MARY BIRD PERKINS – BATON ROUGE
Investigators
Bienvenu, Bryan 225-767-1311
Billings, Frederic 225-767-1311
Hanson, David S. 225-767-1311
Patten, Judd 225-767-1311
Schmeeckle, Kelly…………..225-767-1311
Spell, Derrick 225-767-1311
Fields, Robert S 225-767-0847
Henkelmann, Greg 225-767-0847
Johnson, Sheldon 225-767-0847
King, Maurice 225-767-0847
Levine, Renee 225-767-0847
Lo, Kenneth 225-767-0847
Sanders, Mary Ella…………..225-767-0847
Wood, Charles……………….225-767-0847
Staff
Knox, Cindy…………………..225-2151342
Hebert, Stephen……………...225-215-1204
Bryant, Donna ………………..225-215-1348
Holmes, Donna
Kantner, Alyce…………………225-215-1206
Gibbons, Jennifer
Thomassie, Amy
FAX …………………………….225-768-7601
Regulatory
Reyes, Maria …………………225-215-1249
ONCOLOGICS
Investigators
Deland, M. Maitland 337-706-8960
Harwood, Andrew R. ”
Krawczy, Julian J “
Prellop, Perri B. “
Wilt, Stephen R. “
Nurse:
Cangelosi, Joi (337) 237-2057
CANCER CARE SPECIALISTS
Investigators
Doria, Raul M.D. 985-857-8093
Gamble, Robert M.D. 985-857-8093
McGaw, Harry 985-857-8093
Nurse:
Toups, Ann 985-850-6300
|BRAIN |
|CCCWFU |Life expectancy of at least > 30 weeks. | |MBPCC |
|91105: Phase III Double Blind,|Must have received a prior course of at least 30 Gy fractionated whole or partial brain | |CCS |
|Placebo Controlled Study of |irradiation for treatment of a primary brain tumor or metastatic disease to the brain. |Arm A: |Oncologics |
|Donepezil in Irradiated Brain |Must have completed radiation > 6 months prior to enrollment and have no radiographic evidence of|Donepezil tablets x 24 weeks | |
| |brain disease, or stable brain disease defined as no evidence of tumor progression in the 3 |(Week 1-6: one 5 mg tablet per day) | |
| |months prior to enrollment. |(Weeks 7-24: two 5 mg tablets per | |
| |Patients who have undergone one or more treatments with single fraction stereotactic radiosurgery| | |
| |(SRS) in addition to whole or partial brain irradiation are eligible, as long as the SRS was |Arm B: | |
| |completed > 6 months prior to registration if NED or stable disease. |Placebo tablets x 24 weeks | |
| |Patients who have received PCI (prophylactic cranial irradiation) are eligible. |(Week 1-6: one tablet per day) | |
| |Karnofsky Performance Status must be > 60 or ECOG 0-2. |(Weeks 7-24: two tablets per day) | |
| |Treatment with steroids, anti-cholinergics, anti-epileptics, anti-depressants, and /or | | |
| |sedatives/benzodiazepines is acceptable, but the patient must be on a stable or decreasing dose | | |
| |at the time of study entry. | | |
| |Patients using narcotic analgesics on a stable dose and/or prn basis are eligible. | | |
| |Patients currently on a stable dose of Methylphenidate or Dextramphetamine are eligible. | | |
| |For patients with brain metastases, if extracranial primary or metastatic disease is present, it | | |
| |must have responded to local and/or systemic treatment. Must be stable in the 3 months prior to | | |
| |enrollment. | | |
| |Patient must not have any planned therapy, including surgery, brain radiation of any type, | | |
| |chemotherapy, or immunotherapy during the next 30 weeks for brain or extracranial primary | | |
| |metastatic disease. | | |
| |Hormonal therapy for patients with breast or prostate cancer is acceptable. | | |
| |Breast patients receiving therapy with Herceptin are allowed. | | |
| |Patients cannot be currently taking dementia drugs, cognitive enhancers, neuroleptics, and/or | | |
| |anti-parkinsonian agents. For patients who have used these drugs in the past, they must not have | | |
| |used them in the 2 weeks prior to enrolling on the study. | | |
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|1 rx credit | | | |
|BRAIN |
|IRB #7591C: RTOG 0825 PHASE III|· Patients must have histologically proven diagnosis of WHO grade IV glioblastoma or |Arm1 = RT + TMZ + placebo |MBPCC |
|DOUBLE-BLIND PLACEBO-CONTROLLED|gliosarcoma confirmed by central review prior to step 2 registration. Patients must have tumor |Arm2 = RT + TMZ + bevacizumab |MCLNO- pending |
|TRIAL OF CONVENTIONAL |tissue that is determined by central pathology review prior to step 2 registration to be |Initiation of chemoradiation: | |
|CONCURRENT CHEMORADIATION AND |adequate for MGMT analysis and determination of molecular profile. |Radiation 60 Gy in 2 Gy fractions over 6 weeks concurrently with | |
|ADJUVANT TEMOZOLOMIDE PLUS |· Patients’ tumor must have a supratentorial component. |Temozolomide 75 mg/m2 PO QD during radiation course | |
|BEVACIZUMAB VERSUS CONVENTIONAL|· Patients must have recovered from surgery, postoperative infection, and other complications | | |
|CONCURRENT CHEMORADIATION AND |before step 2 registration. |After the first three weeks of chemoradiation, patients are | |
|ADJUVANT TEMOZOLOMIDE IN |· Patients must have a diagnostic contrast-enhanced MRI of the brain performed preoperatively |randomized and begin placebo or bevacizumab while continuing | |
|PATIENTS WITH NEWLY DIAGNOSED |and postoperatively prior to initiation of radiotherapy; the postoperative scan must be |chemoradiation | |
|GLIOBLASTOMA |performed ≤ 28 days prior to step 1 registration. |Beginning Week 4 of chemoradiation: | |
| |· Patients must have an MRI or CT scan ≤ 10 days prior to the start of radiation therapy, and it|Placebo or bevacizumab 10 mg/kg IV Days 1 and 15 of each 28-day | |
|THERAPEUTIC CREDITS: 1.0 |must not demonstrate significant postoperative hemorrhage (defined as > 1 cm diameter of blood).|cycle for 2 doses during chemoradiation and 1 additional dose 2 | |
|CANCER CONTROL CREDITS: 0.5 |· Patients must document steroid doses ≤ 14 days prior to step 2 registration. |weeks after the completion of chemoradiation. | |
| |· Patients must have Karnofsky performance status ≥ 70. | | |
| |· Patients must have systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 90 mg Hg within|Beginning 4 weeks after completion of chemo- radiation: | |
| |14 days prior to step 2 registration. |Temozolomide 150-200 mg/m2 PO Days 1-5 q 28 days x 6-12 cycles | |
| |· Patients who are on full-dose anticoagulation must not have any active bleeding or |concurrently with | |
| |pathological condition that carries a high-risk of bleeding and must have an in-range INR on a |Placebo or bevacizumab 10 mg/kg IV Days 1 and 15 q 28 days x 6-12 | |
| |stable dose. |cycles | |
| |· Female patients must not be pregnant or lactating and all patients of childbearing potential | | |
| |must practice adequate contraception. | | |
| |· Patients must not have had prior invasive malignancy, except non-melanomatous skin cancer, | | |
| |unless disease free for ≥ 3 years per Section 3.2.1. | | |
| |· Patients must not have recurrent or multifocal malignant gliomas. | | |
| |· Patients must not have metastases detected below the tentorium or beyond the cranial vault. | | |
| |· Patients must not have had prior chemotherapy or radiosensitizers for cancers of the head and | | |
| |neck region, nor any prior temozolomide or bevacizumab for any reason. | | |
| |· Patients must not have had prior use of Gliadel wafers or any other intratumoral or | | |
| |intracavitary treatment. | | |
| |· Patients must not have had prior radiotherapy to the head or neck (except for T1 glottic | | |
| |cancer) resulting in overlap of radiation fields. | | |
| |· Patients must not have severe, active co-morbidity, as defined in Section 3.2.6. | | |
| |· Patients must not be treated on any other therapeutic clinical protocols ≤ 30 days prior to | | |
| |study entry or during participation in the study. | | |
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|BRAIN |
|TITLE |ElIGIBILITY |TREATMENT |LOCATION |
| |Pre-registration Eligibility: |Arm A (Radiation): |MBPCC |
|ECOG 3F05 Phase III Study of |· Patients must have pathological diagnosis of astrocytoma grade 2, oligodendroglioma grade 2, |Radiation* to 5040 cGy in 28 daily fractions of 180 cGy each, | |
|Radiation Therapy with or |or oligoastrocytoma grade 2 (mixed glioma containing astrocytoma and oligodendroglioma). |given M-F for 5 ½ weeks. |CCS |
|without Temozolomide for |Patients must not have pilocytic astrocytoma, ganglioglioma, pleomorphic xanthastrocytoma, or | | |
|Symptomatic or Progressive |dysembryoplastic neuroepithelial tumors. |Arm B (Radiation + Temozolomide): | |
|Low-Grade Gliomas |· The tumors must be supratentorially located. |Radiation* to 5040 cGy in 28 daily fractions of 180 cGy each, | |
| |· Patients must be ≥ 18 years of age with Karnofsky PS ≥ 60%. |given M-F for 5 ½ weeks. | |
| |· Patients must have paraffin-embedded tumor specimen available for submission for confirmation | | |
| |of pathological diagnosis and determination of 1p/19q deletion status. |Concurrently with | |
|THERAPEUTIC CREDITS: 1.0 |· Patients must currently have at least one of the following a) uncontrolled symptoms (i.e., HA |TMZ 75 mg/m2 QD during radiotherapy for approximately 5 ½ weeks. | |
|CANCER CONTROL CREDITS: 0.5 |associated with mass effect, uncontrolled seizures despite two different antiepileptic drug | | |
| |regimens, focal neurological symptoms, cognitive symptoms or deficits), b) tumor progression by |Followed approximately 28 days later by | |
| |serial MRIs (i.e., new or progressive enhancement or new or progressive T2 or FLAIR signal |TMZ 150** mg/m2 Days 1-5 q 28 days | |
| |abnormality), or c) age ≥ 40 years. |Give a total of 12 28-day cycles | |
| |· Patients must be able to undergo MRI with and without contrast. | | |
| |· Patients must not have had previous radiation, cytotoxic chemotherapy, radiosurgery, or |* Can be 3D conformal or IMRT. | |
| |investigational treatment directed at the brain tumor at any time. There is no limit on the |** If tolerated, dose can be increased to 200 mg/m2 beginning | |
| |number of previous surgical procedures on this tumor. |Cycle 2. | |
| |· Patients must not have had previous RT to the head for any condition, unless the ports for | | |
| |that radiation completely excluded the brain. | | |
| |· Patients must not have any diagnosed malignancy (except for non-melanoma skin cancer or | | |
| |cervical cancer in situ) unless they have been disease-free for ≥ 5 years. | | |
| |· Patients must not have medical conditions that increase the risk of radiation or TMZ | | |
| |chemotherapy. No uncontrolled infection, no known positivity for HIV, no other disorder limiting| | |
| |expected survival to < 5 years. | | |
| |· Patients may have undergone gross total resection and have no detectable residual disease. | | |
| |Randomization Eligibility: | | |
| |· Patients must be confirmed eligible by central review of pathology, and must have completed | | |
| |1p/19q deletion assessment. | | |
| |· Patients must be able to start RT within 2 weeks or 10 working days at a qualified center and | | |
| |able to start TMZ at a qualified center within 2 weeks or 10 working days of randomization. | | |
| |· Patients must not be pregnant or breastfeeding; women of childbearing potential and sexually | | |
| |active males are strongly advised to use an accepted and effective method of contraception. | | |
| |· Patients must be at least two weeks post any brain surgery (whether stereotactic biopsy, open | | |
| |biopsy or resection) at the time of randomization | | |
|BREAST |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|IRB# 6389: NSABP B-39/RTOG |• Patients must have stage 0, I, or II breast cancer. |Group 1: |LSUHSC |
|0413: A Randomized Phase III |If stage II, tumor size must be 60 Gy |Oncologics |
|Versus Partial Breast |• Gross disease must be unifocal with pathologic tumor size 18 years; Life expectancy >10 years. |radiation | |
| |• All suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or | | |
| |internal mammary nodes, or microcalicifications, densities, or palpable abnormalities must be |For all PBI techniques: RT given to index quadrant only, BID | |
| |biopsy-proven negative (see Secs. 6.2.5 and 6.2.6). |(with a fraction separation of at least 6 hours), for a total of | |
| | |10 treatments given on 5 days over a period of 5-10 days) | |
|1 rx credit | |******************************************************* | |
|0.5 cc credit | |If chemotherapy is to be given (at the discretion of the | |
| | |patient’s medical oncologist), it will be given prior to WBI | |
| | |(Group 1) or following PBI (Group 2). At least 2 weeks should | |
| | |separate the two modalities. | |
| | |If hormone therapy is to be given, it should begin between 3 and | |
| | |12 weeks after the completion of any chemotherapy. In patients | |
| | |not receiving chemotherapy, hormones may begin before, during or | |
| | |after radiation. | |
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|BREAST |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|NSABP B-43: A Phase III |Only patients who had a lumpectomy are eligible. Re-excision(s) to achieve tumor-free margins are |Group 1*: Radiation Therapy |MCLNO |
|Clinical Trial Comparing |permitted, but mastectomy is not. |Group 2*: Radiation Therapy + Trastuzumab x 2 doses |Veith |
|Trastuzumab Given Concurrently|Pre-entry central HER2 testing (see Sections 6.1 and 6.2 and Appendix C) is required for all |Dose 1: 8 mg/kg IV |MOL |
|with Radiation Therapy and |patients. |Dose 2: 6 mg/kg IV |MBPCC |
|Radiation Therapy Alone for |Patients must have an ECOG performance status of 0 or 1 |given 3 weeks after Dose 1 |CCS Thibodaux |
|Women with HER2-Positive |On histologic examination, the tumor must be ductal carcinoma in situ (DCIS). (Patients with mixed| | |
|Ductal Carcinoma In Situ |DCIS and lobular carcinoma in situ [LCIS] are eligible.) The DCIS must be HER2-positive as |Trastuzumab will be provided free of charge by Genentech, Inc., | |
|Resected by Lumpectomy |determined by central testing |and distributed by the NCI Pharmaceutical Management Branch | |
| |Estrogen and/or progesterone receptor status must be determined prior to randomization. (Patients |(PMB). | |
| |with DCIS that is hormone receptor positive or negative are eligible.) | | |
| |All DCIS must have been resected by lumpectomy. The margins of the resected specimen must be | | |
| |histologically free of DCIS. For patients in whom pathologic examination demonstrates DCIS present| | |
| |at the line of resection, re-excision(s) may be performed to obtain clear margins. (Patients who | | |
| |require mastectomy are not eligible.) | | |
| |If axillary staging is performed, nodal staging must be pN0, pN0(i–), pN0(i+) which is defined as | | |
| |isolated tumor cells ≤ 0.2 mm, regardless of the method of detection, i.e., IHC or H&E, pN0(mol–),| | |
| |or pN0(mol+). Note: Axillary staging is not required. | | |
|1 rx credit |The interval between the last surgery for excision of DCIS (lumpectomy or reexcision of lumpectomy| | |
| |margins) and randomization must be no more than 120 days. | | |
|N063D/BIG 2-06, ALTTO: |Patients with histologically-confirmed, nonmetastatic, operable primary invasive adenocarcinoma of|Treatment Plan |MCLNO |
|Adjuvant Lapatinib and/or |the breast. |See Section 5.0 for Complete Treatment Details |Veith |
|Trastuzumab Treatment |· Tumor must be adequately excised (see Section 4.2.3.b for exception). |Design 2 |MOL |
|Optimization Study: A |· Axilla must be dissected; patients must be axillary node positive or node negative with a tumor |Trastuzumab Arm |MBPCC |
|randomized, multi-centre, |≥ 1.0 cm. |· Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Trastuzumab |EKL |
|open-label, phase III study of|· Hormone receptor status must be known (ER/PgR or ER alone). |2mg/kg* IV q 7 days x 12 weeks, followed by Trastuzumab 6mg/kg IV|CCS |
|adjuvant lapatinib, |· Patients must have received at least four cycles of an approved anthracycline-based (neo-) |q 21 days x 40 weeks | |
|trastuzumab, their sequence |adjuvant chemotherapy regimen (see Section 4.1, Table 5 of the protocol). |Lapatinib Arm | |
|and their combination in |· There must be over expression and/or amplification of HER2 in the invasive component of the |· Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Lapatinib 1500| |
|patients with HER2/ErbB2 |primary tumor which must be confirmed by the central laboratory prior to randomization. |mg PO QD x 52 weeks Trastuzumab followed by Lapatinib Arm · | |
|positive primary breast cancer|· Patients must not have a history of any prior (ipsi and/or contralateral) invasive breast |Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Trastuzumab 2 | |
| |carcinoma. |mg/kg* IV q 7 days x 12 weeks 6-week washout, followed by | |
| |· Patients must not have bilateral tumors. |Lapatinib 1500 mg PO QD x 34 weeks | |
| |· Patients must not have a clinically staged T4 tumor, including inflammatory breast cancer. |Lapatinib combined with Trastuzumab Arm | |
| |· Patients must not have had (neo-) or adjuvant chemotherapy using peripheral stem cell or bone |· Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Lapatinib 750 | |
| |marrow stem cell support. |mg PO QD x 12 weeks, and · Trastuzumab 2mg/kg* IV q 7 days x 12 | |
| |· Patients must not have had any prior mediastinal irradiation except internal mammary node |weeks, followed by Lapatinib 1000 mg PO QD x 40 weeks, with | |
| |irradiation for the present breast cancer. |Trastuzumab 6mg/kg IV q 21 days x 40 weeks | |
| |· Patients must not have positive or suspicious internal mammary nodes identified by sentinel node|* A loading dose of trastuzumab is given on Day 1that is | |
| |technique which will have not been irradiated or will not be irradiated, nor supraclavicular lymph|2 mg/kg higher than the regular dose shown here. | |
| |node involvement (confirmed by FNA or biopsy). | | |
| |· Patients must not have had prior use of anti-HER2 therapy for any reason or other prior biologic| | |
| |or immunotherapy for breast cancer. | | |
|1 rx credit |· Patients must not have concurrent anti-cancer treatment, except hormonal therapy or radiotherapy| | |
| |for the present breast cancer. | | |
|CALGB 70604: A Randomized, |• Histo confirmed adenocarcinoma of prostate or breast or multiple myloma |zoledronic acid (every 12 weeks) |MBPCC |
|Phase III Study of Standard |At least 1 bone mets confirmed by radiographic imaging |versus |Veith |
|Dosing versus Longer Dosing |No prior IV bisphosphonate tx |zoledronic acid (every 4 weeks) |CCS |
|Interval of Zoledronic Acid in|No prior radiopharmaceuticals | |LSUHSC |
|Metastatic Cancer |≥ 4 week since completion of radio-therapy | |MOL |
| |No current investigational therapy | |MCLNO |
|1 cc credit |No brain mets | | |
| |ECOG status of 0-2 | | |
|IRB# 7310: Z1071: A Phase II |ECOG/Zubrod Performance Status 0-1 |Surgery followed by chemo |MBPCC |
|Study Evaluating the Role of |Histologic diagnosis of invasive breast cancer, clinical stage T1-4 N1-2 (excluding inflammatory | |Veith |
|Sentinel Lymph Node Surgery |breast cancer). | |CCS |
|and Axillary Lymph Node |FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of | |LSUHSC |
|Dissection Following |diagnosis and prior to preoperative chemotherapy. | |MOL |
|Preoperative Chemotherapy in |Preoperative chemotherapy must be completed or planned for patient. | |MCLNO |
|Women with Node Positive |Non-pregnant and non-lactating (breast feeding). | | |
|Breast Cancer (T1-4, N1-2, M0)|No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of | | |
|at Initial Diagnosis |hidradenitis. | | |
| |No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary | | |
|1 rx credit |status. | | |
|CALGB 40503 Endocrine Therapy | Patients must be women with histologic confirmation of invasive cancer of the breast in either |Arm I: |MBPCC |
|in Combination with ANTI-VEGF |primary or metastatic setting; It must be Stage IV disease or Stage IIIB disease not amenable to |Endocrine therapy* |CCS |
|Therapy: A Randomized, |local therapy. |Bevacizumab 15 mg/kg IV q 21days |Veith |
|Double-Blind, |Tumors must be either ER and/or PgR positive. |Ovarian suppression if required# |EKL- pending |
|Placebo-Controlled Phase III |Patients may be postmenopausal (per criteria in Section 4.5.2) or must undergo ovarian suppression|Continue until progressive disease |MCLNO- pending |
|Trial of Endocrine Therapy |(per Section 8.3) starting prior to or on day 1 of protocol therapy. | | |
|Alone or Endocrine Therapy |Patients must have measurable or non-measurable disease by RECIST criteria (per Section 4.6). |Arm II: | |
|Plus Bevacizumab (NSC 704865; |Patients may not have had prior endocrine therapy in the metastatic setting, unless tamoxifen or |Endocrine therapy* | |
|IND 7921) for Women with |an AI was started within 4 weeks prior to registration to facilitate the enrollment of patients |Ovarian suppression if required# | |
|Hormone Receptorpositive |who recently started 1st-line endocrine therapy for metastatic breast cancer. |Continue until progressive disease | |
|Advanced Breast Cancer |Patients may have had prior endocrine therapy in the adjuvant setting. | | |
| |Patients may have had prior treatment with ovarian suppression in either the adjuvant or |*The choice of endocrine therapy (letrozole or tamoxifen) is up | |
|rx credit |metastatic setting (see Section 7.7.1). |to the treating physician (see Section 8.3 for recommendations). | |
| |Patients may not have had any prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy. |# Ovarian suppression for premenopausal women must be medical or | |
| |Any prior RT must have been completed and all toxicities resolved at least two weeks prior to |surgical (not via radiation). See Section 8.4 for choices of LHRH| |
| |registration. |agonists. | |
| |Patients may have had chemotherapy in the adjuvant or neoaduvant setting. Any prior chemotherapy | | |
| |must have been completed at least 12 months prior to registration, and all toxicities must have | | |
| |resolved. | | |
| |Taxane-related neurotoxicity must have resolved to sensory grade < 2 and no motor neuropathy of | | |
| |any grade is allowed. | | |
| |Patients may have received one prior chemotherapy regimen for metastatic disease. | | |
| |Treatment with bisphosphonates is allowed and recommended per ASCO guidelines. | | |
| |Patients must not have had any major surgical procedure, open biopsy, or significant traumatic | | |
| |injury | | |
| |within 28 days prior to study registration, and must have fully recovered from such procedures. | | |
| |Patients must not anticipate any major surgery during the course of the study. | | |
| |Patients must not have had a core biopsy or other minor surgical procedure within 7 days prior to | | |
| |registration (VAD placement is allowed within 7 days of registration). | | |
| |Patients must not have history of abdominal fistula, intra-abdominal abscess, or significant | | |
| |bleeding episodes (e.g., hemoptysis, upper or lower GIB) within 6 months prior to registration or | | |
| |a history of GI perforation within 12 months prior to registration. | | |
| |Patients must not have clinically significant CV disease, including uncontrolled HTN | | |
| |4.12.1), history of MI or unstable angina within 6 months, NYHA Grade 2 or greater CHF, | | |
| |symptomatic PVD, or significant vascular disease or arterial thrombotic events. | | |
| |♣ Patients may be on full dose anticoagulation for prior conditions such as venous thrombosis or | | |
| |atrial | | |
| |fibrillation, but not for the treatment of prior arterial thrombotic events; patients must be on a| | |
| |stable | | |
| |dose of warfarin and have an in-range INR, or be on a stable dose of LMWH. Patients may be | | |
| |receiving antiplatelet agents, as well as daily prophylactic ASA or anticoagulation for atrial | | |
| |fibrillation. | | |
| |♣ Patients must not have non-healing wound, ulcer, or bone fracture. | | |
| |♣ Patients must not be pregnant or nursing at any time during the study. | | |
|CANCER CONTROL |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|See specific disease site for current cancer control studies. |
|GASTROINTESTINAL |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|IRB# 6736: SWOG C80405: A Phase III |· Patients with histologically or cytologically documented locally advanced or metastatic |Arm A: |LSU |
|Trial Of Irinotecan/5-Fu/Leucovorin |adenocarcinoma of the colon or rectum that has not been resected. |• Bevacizumab 5mg/kg IV q 2 weeks |MBPCC |
|Or Oxaliplatin/5-Fu/Leucovorin With |· Patients may have a history of colorectal cancer treated by surgical resection and now have|• FOLFOX/FOLFIRI* q 2 weeks |Med Onc |
|Bevacizumab, Or Cetuximab (C225), Or |evidence of metastatic cancer. |• 1 cycle = 8 weeks |EKL |
|With The Combination Of Bevacizumab |· Patients must have a wildtype K-ras gene as determined by the SWOG Solid Tumor Repository. | |MCLNO |
|And Cetuximab For Patients With |· Patients may not have received any prior systemic treatment for advanced or metastatic |Arm B |CCS |
|Untreated Metastatic Adenocarcinoma |disease, but may have received prior adjuvant chemo that concluded > 12 months prior to |• Cetuximab 400mg/m2 IV on Day 1, then Cetuximab 250mg/m2 IV | |
|Of The Colon Or Rectum |registration or prior neoadjuvent chemo-radiation with capecitabine or 5-FU. |Weekly thereafter | |
| |· No prior exposure to agents that target VGEF or EGF receptors; no prior exposure to |• FOLFOX/FOLFIRI* q 2 weeks | |
| |bevacizumab or Cetuximab. |• 1 cycle = 8 weeks | |
| |· Patients may not have had prior RT to greater than 25% of bone marrow. | | |
| |· No major surgery < 4 weeks prior. | | |
| |· Patients to receive FOLFIRI may not have evidence of Gilbert’s Syndrome or be known to be |*The decision to use FOLFOX or FOLFIRI is at the | |
| |homozygous for the UGT1A1*28 allele, and those to receive FOLFOX may not have sensory |patient/treating physician’s discretion (while complying with | |
| |peripheral neuropathy of > grade 2 at baseline. |eligibility criteria 4.5 and 4.6). | |
|1 rx credit | | | |
| | |Cetuximab is provided free of charge | |
| E3205: Phase II Trial of Cetuximab |histologically proven stage I-IIIB invasive anal canal or perianal (anal margin) squamous |Cetuximab Plus Cisplatin, 5-Fluorouracil and Radiation |MBPCC |
|Plus Cisplatin, 5-Fluorouracil and |cell carcinoma | |Med Onc |
|Radiation in Immunocompetent Patients|must be > 18 years | |Veith |
|with Anal Carcinoma |ECOG performance status of 0-2 |Cetuximab is provided free of charge |MCLNO |
| |No concurrent malignancies | |EKL |
| |no history of prior radiation or chemotherapy for this malignancy | |CCS |
| |must not have had prior potentially curative surgery (abdominal, peritoneal resection) for | | |
| |carcinoma of the anus | | |
| |must not have an active infection, uncontrolled diabetes, congestive heart failure > NYHA | | |
|1 rx credit |Class II, CVA/TIA, uncontrolled hypertension, unstable angina or myocardial infarction within| | |
| |the last 6 months | | |
| |no hx of rheumatic disorders, irritable bowel disease, or inflammatory bowel disease | | |
| |no HIV | | |
| |see protocol for labs | | |
|CALGB 80702: A Phase III Trial of 6 | Documented adenocarcinoma of the colon and at least one pathologically confirmed positive |Treatment must begin between 21 and 56 days after definitive |EKL |
|versus 12 Treatments of Adjuvant |lymph node. |surgical resection of primary tumor and within 14 days of |MBP |
|FOLFOX Plus Celecoxib or |· Patients must not have rectal cancer (i.e., the tumor must be at least 12 cm from the anal |randomization. |CCS |
|Placebo for Patients with Resected |verge). |One cycle = 14 days of treatment |Veith |
|Stage III Colon Cancer |· Patients must have had complete resection of the tumors; if tumor is adherent to adjacent | |MCLNO |
| |structures, patients must have documentation of en bloc R0 resection. |Medications: | |
|1 tx credit |· Patients must not have any evidence of residual involved lymph node disease or metastatic |FOLFOX: | |
| |disease at the time of registration. |Oxaliplatin 85 mg/m2 IV over 2 hours followed by | |
| |· Patients may have synchronous colon cancers, but must not have synchronous colon and rectal |Leucovorin 400 mg/m2 IV over 2 hours (may be administered | |
| |primary tumors. |concurrently via separate infusion lines) followed by | |
| |· Patients must not use NSAIDs at any dose or aspirin at > 325 mg more than two times per week|5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 con-tinuous IV | |
| |on average (low dose aspirin, ≤ 100 mg/day is permitted). |infusion over 46-48 hours. | |
| |· Patients must not have previous or concurrent malignancy, except treated basal cell or | | |
| |squamous cell skin cancer, treated in situ cervical cancer, treated lobular or ductal |Celecoxib: 400 mg daily PO | |
| |carcinoma in situ in one breast, or any other cancer for which the patient has been disease |Arm A: 12 cycles of FOLFOX + Placebo daily | |
| |free for ≥ 5 years. |Arm B: 12 cycles of FOLFOX + Celecoxib daily | |
| |· Patients must not have neurosensory or neuromotor toxicity ≥ grade 2 at time of |Arm C: 6 cycles of FOLFOX + Placebo daily | |
| |registration. |Arm D: 6 cycles of FOLFOX + Celecoxib daily | |
| |· Patients must not have known allergy to platinum compounds, or prior allergic reaction or |Celecoxib/placebo will continue for 3 years or until | |
| |hypersensitivity to sulfonamides, celecoxib or NSAIDs. |unacceptable toxicity. | |
| |· Patients must not have a history of upper GI ulceration, bleeding or perforation within the | | |
| |past 3 years. | | |
| |· Patients must not have symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.| | |
| |· Patients must not have cardiac risk factors, including uncontrolled high blood pressure | | |
| |(systolic BP >150), unstable angina, history of documented myocardial infarction or | | |
| |cerebrovascular accident; or NYHA class II or IV heart failure. | | |
| |· ECOG performance status 0, 1, or 2. | | |
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|NSABP PROTOCOL P-5 |Selected eligibility criteria: |P-5 study therapy |MBP |
|Statin Polyp Prevention Trial in |• Resected adenocarcinoma of the colon staged as AJCC StageI or II |• Each patient will take 1 tablet of the P-5 study drug once |EKL |
|Patients |• Surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to |daily for 5 years. Patients will take |CCS |
|with Resected Colon Cancer |randomization (laparoscopicallyassisted colectomy is permitted) |either: |Veith |
| |• Patients must > 18 years old |− rosuvastatin 10 mg (one tablet) orally without regard to |MCLNO |
|1cc credit |• Adjuvant therapy, if given, must be completed before randomization |meals, once a day for 5 years, or | |
| |• Patients taking cardioprotective low-dose aspirin must be able and willing to continue at |− placebo (one tablet) orally without regard to meals, once a | |
| |the same dose |day for 5 years. | |
| |• Colonoscopy (preop or postop) to the cecum or small bowel anastomosis with removal of all | | |
| |observed polyps within 180 days prior to randomization |This is a double-blind trial. Neither the patient nor the | |
| |• Within 90 days prior to randomization: |investigator/health care providers will | |
| |o Serum creatinine must be < 1.5 x ULN |know the treatment assignment until the completion of the | |
| |o AST or ALT < 3.0 x ULN and total bilirubin must be < 1.5 x |trial. | |
| |ULN (If AST & ALT obtained, both must be < 3.0 x ULN) | | |
| |Selected ineligibility criteria: | | |
| |• Tumor with the distal border located 325 mg) or use of NSAIDs for more than an | | |
| |average of 3 days per month | | |
| |• Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the | | |
| |stomach or small bowel, or other disease significantly affecting GI function | | |
| |• Hypersensitivity or intolerance to statins | | |
| |• Unwillingness to discontinue chronic use of NSAIDs other than | | |
| |cardioprotective low-dose aspirin | | |
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|IRB # 7647C: CALGB 80802 Phase III |• pathologically or cytologically proven HCC. Known mixed histology or fibrolamellar variant |Arm A: |MBPCC |
|randomized study of sorafenib (IND |is not allowed. |Doxorubicin 60 mg/m2 IV Day 1 |CCS |
|69896, NSC 724772) plus doxorubicin |• The disease must be locally advanced or metastatic. Locally advanced disease is defined as |May give G-CSF x three days or GM-CSF x one day after each |Veith |
|versus sorafenib in patients with |disease deemed to be unresectable or non-eligible for transplant without distant metastases. |doxorubicin dose |EKL- pending |
|advanced hepatocellular carcinoma |• Patients must have measurable disease that is accurately measurable in at least one |Sorafenib 400 mg PO BID QD |MCLNO- pending |
|(HCC) |dimension as ≥ 2 cm with conventional techniques or ≥ 1 cm with spiral CT scan. |Give six 21-days cycles of doxorubicin and sorafenib, and then| |
| |• Patents must not have had prior adjuvant sorafenib or other Raf/VEGF inhibitors. Other prior|continue sorafenib until unacceptable toxicity or disease | |
|THERAPEUTIC CREDITS: 1.7 TOTAL (1.0 |adjuvant therapy is allowed if completed > 6 months prior to study entry with documented |progression. | |
|for 80802 study; 0.3 for 150902 |recurrence of HCC. | | |
|Ancillary; 0.3 for 580901 Ancillary; |• Patients may have had prior locoregional therapies such as embolization, chemo-embolization |Arm B: | |
|0.1 for 60901 Ancillary) |(except with doxorubicin), radiation, radioactive microspheres, etc., provided that they |Sorafenib 400 mg PO BID QD | |
|CANCER CONTROL CREDITS: 0 |either have a target lesion that has not been subjected to local therapy and/or the target |Continue sorafenib until unacceptable toxicity or disease | |
| |lesion(s) within the field has shown an increase of ≥ 25% in size since last treatment. Such |progression. | |
| |therapy must be completed ≥ 4 weeks prior to study entry. | | |
| |• Patients must not have had prior systemic therapy for metastatic disease. | | |
| |• Patients may have had antiviral treatment, but interferon therapy must be stopped ≥ 4 weeks | | |
| |prior to registration. | | |
| |• no prior history of allograft, including liver and bone marrow transplants. | | |
| |• Patients must not have known CNS tumors including brain metastases. | | |
| |• Patients must not have clinically significant GI bleeding events requiring intervention, | | |
| |transfusion, or admission to hospital within 30 days prior to study entry. | | |
| |• Patients must have completed any major surgery ≥ 4 weeks from study entry. | | |
| |• Patients must not be taking concomitant treatment with Rifampin or St. John’s Wort; these | | |
| |drugs should be discontinued ≥ 4 weeks prior to starting protocol treatment. | | |
| |• Patients with history of HTN must be well-controlled on an anti-HTN regimen. | | |
| |• Patients must not have significant cardiac history, i.e., CHF > Class II NYHA, MI within 6 | | |
| |months prior to study entry, cardiac arrhythmias requiring therapy other than beta-blockers or| | |
| |digoxin, or serious myocardial dysfunction (i.e., LVEF < 45% or < institutional normal level).| | |
| |• Patients must not have a history of bleeding diathesis. | | |
| |• Patients must not be receiving combination ART for HIV. | | |
| |• Patients must not be pregnant or nursing, and women of childbearing potential and males must| | |
| |agree to use adequate contraception prior to the initiation of study treatment, for the | | |
| |duration of the study participation, and for 30 days after completing study | | |
| |• Patients must be ≥ 18 years of age with ECOG PS of 0-2. | | |
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|NCCTG N08CB A Phase III Randomized, |Histologically confirmed adenocarcinoma of the colon or rectum. Has undergone curative |Calcium gluconate plus magnesium sulfate 1 g of each agent IV |Veith |
|Placebo-Controlled, Double-Blind |resection and is considered to have stage II orstage III disease or completely resected stage |in 100 ml D5W over 30 minutes immediately before and after |MCLNO |
|Study of Intravenous |IV disease with no evidence of residual tumor. |each oxaliplatin administration | |
|Calcium/Magnesium in Two Different |Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy with 85 mg/m2 | | |
|Versions to Prevent |oxaliplatin every 2 weeks. This includes, for instance, FOLFOX4 or modified FOLFOX Note: |Placebo 100 ml bag of D5W IV over 30 minutes immediately | |
|Oxaliplatin-Induced Sensory |Adjuvant FOLFOX can be conducted with or without bolus 5FU. |before and after each oxaliplatin administration | |
|Neurotoxicity |Definitions | | |
| |FOLFOX4: 2-hour infusion of LV (200 mg/m2/d) with oxaliplatin |Calcium gluconate plus magnesium sulfate 1 g of each agent in | |
| |85 mg/m2 as a 2-hour infusion on day 1; followed by a 5FU bolus (400 mg/m2/d) and |100 ml bag of D5W IV over 30 minutes Immediately before each | |
| |22-hour infusion (600 mg/m2/d) for 2 consecutive days every 2 weeks |oxaliplatin administration PlaceboImmediately after each | |
|CANCER CONTROL CREDITS: 1.0 |MODIFIED FOLFOX6: 2-hour infusion of LV (400 mg/m2) with oxaliplatin 85 mg/m2 as a 2-hour |oxaliplatin administration | |
| |infusion on day 1 followed by a 5FU bolus (400 mg/m2) and 46-hour infusion (2400 mg/m2) every | | |
| |2 weeks | | |
| |Note: Patients using bevacizumab or cetuximab in combination with FOLFOX as part of a clinical| | |
| |trial or clinical practice are eligible. | | |
| |The following laboratory values obtained ≤28 days prior to registration: | | |
| |WBC ≥3000, ANC ≥1500, PLT ≥100,000, HgB ≥10.0, Total bilirubin ≤1.5 x upper normal limit | | |
| |(UNL), Serum creatinine ≤1.5 x UNL, Serum calcium ≤ 1.2 x UNL, Serum magnesium ≤ 1.2 x UNL | | |
| |Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of | | |
| |childbearing potential only. | | |
| |Ability to complete questionnaire(s) by themselves or with assistance. | | |
| |ECOG Performance Status (PS) of 0, 1 or 2. | | |
| |Willingness to return to enrolling institution for follow-up. | | |
| |Patient willing to provide blood sample for research purposes (see Sections 6.12 and 14.0). | | |
| |Central venous access line present, or scheduled to have a central line placed prior to | | |
| |starting chemotherapy and protocol treatment. | | |
| |Exclusion Criteria Any of the following: | | |
| |Pregnant women,nursing women, men or women of childbearing potential who are unwilling to | | |
| |employ adequate contraception since this study involves agents that have known genotoxic, | | |
| |mutagenic and teratogenic effects | | |
| |Pre-existing peripheral neuropathy of any grade. | | |
| |Prior treatment with neurotoxic chemotherapy such as oxaliplatin, cisplatin, taxanes, or vinca| | |
| |alkaloids. | | |
| |On digitalis medication. | | |
| |2nd or 3rd degree AV heart block or a history of 2nd or 3rd degree AV heart block. | | |
| |Note: Bundle branch blocks are allowed. | | |
| |Treatment with 1) the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., | | |
| |Dilantin®), valproic acid (e.g. Depakene®), gabapentin (Neurontin®); pregabalin (Lyrica®); 2) | | |
| |the following neurotropic agents: venlafaxine (Effexor), desvenlafaxine (Pristiq®), | | |
| |milnacipran (Savella®) or duloxetine (Cymbalta); 3) Tricyclic antidepressants (such as | | |
| |amitryptilline) or 4) any other agent specifically being given to prevent or treat neuropathy.| | |
| |A family history of a genetic/familial neuropathy. | | |
|ECOG E7208 A Randomized Phase II |Histologically documented adenocarcinoma (including the histologic variants of |Treatment/ARM A |MBPCC |
|Study of Irinotecan and Cetuximab |adenocarcinoma) of the colon or rectum.Patients K-ras status must be wild type (not mutated). |Cetuximab 500 mg/m2 IV q 14 days |CCS |
|with or without the Anti-Angiogenic |K-ras status determination may bebased on either primary or metastatic tumor. |Irinotecan 180 mg/m2 IV over 60-90 minutes q 14 days |EKL-pending |
|Antibody, Ramucirumab, in Advanced, |Patients must have had prior first-line therapy with oxaliplatin-based |Repeat cycles every 14 days until progression. |Veith |
|K-ras Wild-type Colorectal Cancer |fluoropyrimidinecontaining chemotherapy and bevacizumab for metastatic colorectal cancer. |Treatment/ARM B |MCLNO- pending |
|Following Progression on |Registration within 42 days of documented disease progression. |Ramucirumab 8 mg/kg IV over 60 minutes q 14 days. The dose of | |
|Bevacizumab-Containing Chemotherapy |Registration within 90 and no fewer than 28 days of last dose of bevacizumab. |ramucirumab is to be recalculated should the patients | |
| |Performance Status 0-1. |weight change by 10% | |
|1Tx credit |Adequate Organ Function < 4 weeks prior to registration. |Cetuximab 500 mg/m2 IV q 14 days | |
| |Hematologic: Absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and |Irinotecan 180 mg/m2 IV over 60-90 minutes q 14 days | |
| |platelets ≥ 75,000/μL. |Ramucirumab should be given first, followed by cetuximab and | |
| |Renal: Serum creatinine ≤ 1.5 x the ULN, or creatinine clearance (measured via 24- |then irinotecan. | |
| |hour urine collection) ≥ 40 mL/minute. |Repeat cycles every 14 days until progression. | |
| |Proteinuria: Urinary protein ≤ 1+ on dipstick or routine urinalysis (UA); if urine | | |
| |dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must | | |
| |demonstrate < 1000 mg of protein in 24 hours to allow participation in the study. | | |
| |Hepatic: Total bilirubin ≤ 2.0 mg/dL, and aspartate transaminase (AST) and alanine | | |
| |transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) [or 5.0 x the ULN in the | | |
| |setting of liver metastases]. | | |
| |Coagulation: International Normalized Ratio (INR) ≤ 1.6 (unless receiving | | |
| |anticoagulation therapy). Patients on full-dose anticoagulation must be on a stable | | |
| |dose (minimum duration 14 days) of oral anticoagulant or low molecular weight | | |
| |heparin. If receiving warfarin, the patient must have an INR ≤ 3.0 and no active | | |
| |bleeding (ie, no bleeding within 14 days prior to first dose of study therapy). | | |
| |No prior therapy with drugs other than oxaliplatin and a fluoropyrimidine plus bevacizumab for| | |
| |this diease. If oxaliplatin is discontinued because of side effects, patients must have | | |
| |continued on bevacizumab (normally with a fluoropyrimidine). | | |
| |No clinically significant (equivalent to NCI CTCAE grade 3-4) bleeding episodes within the | | |
| |prior 3 months. | | |
| |No active infection, symptomatic congestive heart failure, unstable angina pectoris, | | |
| |symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic | | |
| |disorder. | | |
| |No uncontrolled or poorly-controlled hypertension despite standard medical management (e.g. | | |
| |consistently SBP > 160 and DBP > 90 mmHg). | | |
| |No major surgery within 28 days prior to randomization, or subcutaneous venous access device | | |
| |placement within 7 days prior to randomization | | |
| |No history of acute arterial thrombotic events within 6 months (including CVA, TIA, MI or | | |
| |unstable angina). | | |
| |No brain or CNS metastases. | | |
| |No other cancer requiring therapy within last three years (except in situ carcinoma or | | |
| |nonmelanoma skin cancer). | | |
| |Patients must not have an acute or subacute intestinal obstruction. | | |
| |Patient must not have a history of inflammatory bowel disease requiring pharmacological and/or| | |
| |surgical intervention within the 12 months prior to randomization. | | |
| |Patient must not have a known allergy to any of the treatment components. | | |
|GENITOURINARY |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|R0534: A Phase III Trial Of |Patients must have adenocarcinoma of the prostate treated primarily with radical prostatectomy, |Arm 1: |MBPCC |
|Short-term Androgen |pathologically proven to be LN negative by pelvic lymphadenopathy (pN0) or LN status |PBRT alone RT to prostate bed to 64.8-70.2 Gy |CCS |
|Deprivation With Pelvic Lymph |pathologically unknown (undissected pelvic LNs [pNx]) | | |
|Node Or Prostate Bed-Only |Post-prostatectomy PSA of ≥ 0.1 and < 2.0 ng/mL |Arm 2: | |
|Radiotherapy (SPORT) In |Disease must be pathologic T3N0/Nx or pathologic T2N0/Nx with or without a positive prostatectomy |PRBT plus NC-STAD LHRH agonist injections to cover 4-6 months | |
|Prostate Cancer Patients With |margin. |E.g., leuprolide, goserelin, triptorelin Antiandrogen for 4-6 | |
|A Rising PSA After Radical |There must be no distant metastases. |months | |
|Prostatectomy |Patients must not have a palpable prostatic fossa abnormality or mass suggestive of recurrence, |Flutamide or bicalutamide | |
| |unless it has been shown by biopsy under US guidance not to contain cancer. |RT to prostate bed to 64.8-70.2 Gy beginning 2 months after start| |
| |Patients must not have N1 disease or pelvic LN enlargement ≥ 1.5 cm in greatest dimension by CT or|of drug therapy | |
| |MRI of the pelvis (unless proven negative by biopsy). | | |
| |Patients must not have received androgen deprivation therapy that was started prior to |Arm 3: | |
| |prostatectomy for > 6 months duration. |PLNRT plus PBRT plus NC-STAD LHRH agonist injections to cover 4-6| |
| |Patients must not have received androgen deprivation therapy that was started after prostatectomy |months | |
| |and prior to registration. |E.g., leuprolide, goserelin, triptorelin Antiandrogen for 4-6 | |
| |Patients must not have had prior pelvic radiotherapy. |months | |
| | |Flutamide or bicalutamide | |
| | |RT to pelvic lymph nodes to 45 Gy beginning 2 months after start | |
| | |of drug therapy | |
| | |RT to prostate bed to 64.8-70.2 Gy beginning 2 months after start| |
| | |of drug therapy | |
|1.5 rx credits | | | |
| | |PBRT = prostate bed radiation therapy | |
| | |PLNRT = pelvic lymph node radiation therapy | |
| | |NC-STAD = neoadjuvent and concurrent short term androgen | |
| | |deprivation. | |
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|GENTOURINARY |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|CALGB-90202: A Randomized, |Histologic documentation of prostate adenocarcinoma (see sec 5.1) |Double-Blinded |MBPCC |
|Double-Blind, Placebo-Controlled|At least one bone metastasis by radiographic imaging (see sec 5.2) |Zoledronic acid: 4 mg IV Q 4 wks |LSUHSC |
|Phase III Study of Early versus |Patients must receive androgen deprivation therapy for treatment of prostate CA (see sec 5.3) |or |Veith |
|Standard Zoledronic Acid to |Hormone therapy (HT) at any point prior to 6 mos before enrollment is prohibited (see sec 5.4) |Placebo: IV Q 4 wks |MOL |
|Prevent Skeletal Related Events |Prior neoadjuvant and/or adjuvant HT is allowed provided that the duration of HT was < 6 mos and| |CCS |
|in Men with |HT was discontinued > 6 mos prior to study entry |Patients who experience PD* during the double blind portion: |MCLNO |
|Prostate Cancer Metastatic to |No prior treatment with a bisphosphonate or with radiopharmaceuticals |Open label Zoledronic acid 4 mg IV Q 3 wks | |
|Bone |≥ 4 wks since completion of prior RT | | |
| |ECOG (CTC) performance status 0-2 |Patient who experience an SRE** at any time during the study: | |
| | |• End protocol treatment | |
|1 rx credit | | | |
| | |*PD: Progressive disease | |
| | |**SRE: Skeletal-related event | |
|CALGB 70604: A Randomized, Phase |• Histo confirmed adenocarcinoma of prostate or breast or MM |zoledronic acid (every 12 weeks) |MBPCC |
|III Study of Standard Dosing |At least 1 bone mets confirmed by radiographic imaging |versus |Veith |
|versus Longer Dosing Interval of |No prior IV bisphosphonate tx |zoledronic acid (every 4 weeks) |CCS |
|Zoledronic Acid in Metastatic |No prior radiopharmaceuticals | |LSUHSC |
|Cancer |≥ 4 week since completion of radio-therapy | |MOL |
| |No current investigational therapy | |MCLNO |
|1 cc credit |No brain mets | | |
| |ECOG status of 0-1 | | |
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|GENTOURINARY |
|TITLE |ELIGIBILTIY |TREATMENT |LOCATION |
|CALGB 90601: A Randomized Double |Histologically documented metastatic or unresectable transitional cell carcinoma of the urinary|Gemcitabine 1000mg/m2 IV on Day 1 and Day 8of every cycle, |Veith |
|Blind Phase III Study comparing |tract (renal pelvis, ureter, bladder, prostate, or urethra), with progressive metastatic or |Cisplatin 70mg/m2 IV on Day 1 and Placebo 15mg/kg Iv on Day 1 |MBPCC |
|Gemcitabine, Cisplatin, and |locally advanced disease. Patients must not be candidates for potentially curative surgery or |every 21 days for 6 cycles then placebo 15mg/kg Iv every 21 days|CCS |
|Bevacizumab to Gemcitabine, |radiotherapy. | | |
|cisplatin and Placebo in Patients|Patients may not have received combination systemic chemotherapy for metastatic disease. |Versus | |
|with Advanced Transitional Cell |For the purposes of this study, radiosensitizng single agent chemotherapy is not considered | | |
|Carcinoma |prior systemic therapy. |Gemcitabine 1000mg/m2 IV on Day 1 and Day 8 of every cycle, | |
| |Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided the interval from |cisplatin 70mg/m2 IV on Day 1, and Bevacizumab 15mg/kg IV on Day| |
|1rx credit |end of therapy to diagnosis of metastatic diseases is at least 1 year. |1 | |
| |> 4 weeks since any intavesical therapy |Then Bevacizumab 15mf/kg IV every 21 days | |
| |No prior treatment with bevacizumab or other angiogenesis inhibitors. | | |
| |No known brain metastases: brain imaging not required. | | |
| |No current congestive heart failure: New York Heart Association Class II, III, or IV | | |
| |Patients with a history of hypertension must be well controlled on a regimen of | | |
| |antihypertensive therapy. | | |
| |Patients on full-dose anticoagulants must be on a stable dose | | |
| |No significant history of bleeding events of GI perforation. | | |
| |No arterial thrombotic events within 6 months | | |
| |No serious or nonhealing wound, ulcer or bone fracture | | |
| |ECOG 0-1 | | |
|IRB #7627 CCCWFU 98110: A |Male prostate cancer survivor previously treated with radiotherapy and who identifies himself |ArginMax at one of three dose levels: |MBPCC |
|Randomized Phase II Dose Finding |as concerned with sexual quality of life, including erectile dysfunction. |Arm 1: 6 capsules placebo bid |Veith |
|Study of ArginMax for Its Effect |Patient must describe himself as having had successful sexual activity prior to the |Arm 2: 3 capsules ArginMax & 3 capsules placebo BID |CCS |
|on Erectile Function and Quality |commencement of radiotherapy. |Arm 3: 6 capsules ArginMax bid | |
|of Life in Survivors of Prostate |Must be interested in sexual activity, and agree to make at least one sexual intercourse |All patients will take the assigned medications twice daily. | |
|Cancer Previously Treated with |attempt every week during the study. |Pill diaries will be provided. | |
|Radiotherapy |The use of PDE-5 inhibitors will be a voluntary component of the trial and will serve as a |All patients will take the same number of pills daily. | |
| |stratification factor. For patients currently taking PDE-5 inhibitors, they must agree to | | |
| |assume the responsibility for the cost of PDE-5 inhibitors treatment during the protocol period| | |
|1cc credit |(8 week period) as this is not covered in the cost of the trial. Patients unable or unwilling | | |
| |to take PDE-5 inhibitors will also be eligible for enrollment on study. PDE-5 inhibitors use | | |
| |will be recorded in the patients‟ diaries. | | |
| |Patients taking PDE-5 inhibitors as part of this study must be on a stable dose of drug for at | | |
| |least one month prior to study entry. | | |
|CALGB 90203: Randomized Phase |Histologic documentation of prostate adenocarcinoma (no small cell, neuroendocrine, or | |MBPCC |
|III Study Of Neo-Adjuvant |transition cell allowed). |Arm A: |LSUHSC |
|Docetaxel And Androgen |· Must have known Gleason sum by biopsy or TURP at registration. |Docetaxel 75 mg/m2 IV Day 1q 21 days x 6 cycles |Veith |
|Deprivation Prior To Radical |· Clinical stage T1-T3a and no radiographic evidence of metastatic disease. |Concurrently with |MOL |
|Prostatectomy Versus Immediate |· Deemed high risk by either a) Kattan nomogram predicted probability of being free from |LHRH agonist x 18-24 weeks |MCLNO |
|Radical Prostatectomy In |biochemical progression at 5 years after surgery of < 60% or b) prostate biopsy Gleason sum ≥ 8.| | |
|Patients With High-Risk, |· No prior treatment for prostate cancer, including surgery (except TURP), LN dissection, |Followed within 60 days by | |
|Clinically Localized Prostate |radiation, or chemotherapy. |Staging pelvic lymphadenectomy | |
|Cancer |· May have received up to 3 months of androgen deprivation therapy. |Radical Prostatectomy* | |
| |· Must be appropriate candidate for radical prostatectomy with life expectancy of > 10 years as | | |
|1.5 rx credits |determined by a urologist. |Arm B: | |
| |· Age > 18 years; ECOG PS 0-1 |· Staging pelvic lymphadenectomy | |
| | |· Radical Prostatectomy* | |
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| | |Docetaxel supplied free of charge | |
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| |• Patients must have a histologically proven diagnosis (via endoscopy or FNA) of primary |Arm 1: |Pending facility |
|RTOG 0436 A Phase III Trial |squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks of|Radiation 180 cGy/fx on Days 1-5, 8-12, 15-19, 22-26, 29-33, and|questionnaire for |
|Evaluating the Addition of |registration. |36-38 (total of 50.4 Gy) |MBPCC |
|Cetuximab to Paclitaxel, |• All disease must be encompassed in the radiotherapy field. |Cetuximab 400 mg/m2 IV on Day 1 | |
|Cisplatin, and Radiation for |• Patients may have celiac, perigastric, mediastinal, or supraclavicular adenopathy. |Cetuximab 250 mg/m2 IV on Days 8, 15, 22, 29, and 36 | |
|Patients With Esophageal Cancer |• Patients may have cervical esophageal carcinoma. |Paclitaxel 50 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 | |
|Who Are Treated Without Surgery |• Disease must be T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a based on diagnostic workup in |Cisplatin 25 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 | |
| |Section 3.1.2. | | |
| |• Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to|Arm 2: | |
|THERAPEUTIC CREDITS: 1.0 |exclude fistula; patients must not have evidence of tracheoesophageal fistula or invasion into |Radiation 180 cGy/fx on Days 1-5, 8-12, 15-19, 22-26, 29-33, and| |
|CANCER CONTROL CREDITS: 0.5 |the trachea or major bronchi. |36-38 (total of 50.4 Gy) | |
| |• Patients must be ≥ 18 and < 75 years of age with Zubrod PS 0-2. |Paclitaxel 50 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 | |
| |• Patients must have a total intake (oral/enteral) of ≥ 1500 kCal/day. |Cisplatin 25 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 | |
| |• Patients must not have prior invasive malignancy (except non-melanomatous skin cancer) unless | | |
| |disease free for at least 2 years. | | |
| |• Patients must not have had prior systemic chemotherapy for esophageal cancer (may have had it | | |
| |for a different cancer). | | |
| |• Patients must not have had prior RT that would result in overlap of planned RT fields. | | |
| |• Patients must not have had prior therapy that specifically and directly targets the EGFR | | |
| |pathway. | | |
| |• Patients must not have had prior platinum-based or paclitaxel-based therapy. | | |
| |• Patients must not have prior allergic reaction to the drugs involved in this study or prior | | |
| |severe infusion reaction to a monoclonal antibody. | | |
| |• Patients must not have any of the following severe, active comorbidities: Unstable angina or | | |
| |CHF requiring hospitalization within the past 3 months, transmural MI within the last 6 months, | | |
| |acute bacterial or fungal infection requiring IV antibiotics at time of registration, COPD | | |
| |exacerbation or other respiratory illness requiring hospitalization or precluding study therapy | | |
| |at the time of registration, or AIDS based on current CDC definition (HIV testing not required | | |
| |for entry to study). | | |
| |• Patients must not be pregnant or nursing. Women of childbearing potential and male | | |
| |participants must practice adequate contraception. | | |
|HEAD AND NECK |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
| E1305: A Phase III Randomized |Histologically or cytologically confirmed SCCHN, from any primary site that is either (a) |Arm A: Cisplatin plus Docetaxel OR Cisplatin plus 5-FU. |MBPCC |
|Trial of Chemotherapy with or |recurrent, judged incurable by surgery or radiation or (b) metastatic. |Vs. |LSUHSC |
|without Bevacizumab in Patients |No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN. |Arm B: Docetaxel plus Cisplatin plus Bevacizumab OR Cisplatin |Veith |
|with Recurrent or Metastatic |No prior bevacizumab, ECOG performance status of 0-1 |plus Bevacizumab plus 5-FU. |MOL |
|Head and Neck Cancer |Previous palliative radiotherapy to the head and neck is allowed if a minimum of 8 weeks has | |MCLNO |
| |elapsed between the end of prior radiotherapy and entry into the protocol. No prior | |CCS |
| |reirradiation in the head and neck region is allowed. A minimum of 3 weeks must elapse between | |EKL |
| |prior radiation to other areas and study entry. | | |
| |Must have recovered from the effects of any surgery, chemotherapy, or radiation therapy, and | | |
| |should be > 4 weeks post surgery. | | |
| |Patients must have measurable disease based on RECIST (see Sec. 6.0). Baseline measurements and | | |
| |evaluations of all sites of disease must be obtained < 4 weeks prior to randomization. Disease | | |
| |in previously irradiated sites is considered measurable if there has been unequivocal disease | | |
| |progression or biopsy-proven residual carcinoma following radiation therapy. | | |
| |Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of| | |
| |radiation therapy. (Radiographic findings are acceptable providing that clear cut measurements | | |
|1 rx credit |can be made). | | |
|RTOG 0920: A PHASE III STUDY OF |Histologically proven squamous cell carcinoma of the head/neck (oral cavity, oropharynx or |Arm 1: Radiation Therapy |EKL |
|POSTOPERATIVE RADIATION THERAPY |larynx; hypopharynx primaries not allowed). No simultaneous primaries or bilateral tumors. |Radiation for a total dose of 60 Gy in 30 fractions of 2 |MBP |
|(IMRT) +/- CETUXIMAB |clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases ≤ 8 weeks of |Gy/day |CCS |
|FOR LOCALLY-ADVANCED RESECTED |registration. | |MCLNO -pending |
|HEAD AND NECK CANCER |Patients must have had gross total resection of primary tumor with curative intent ≤ 7 weeks |Arm 2: Radiation Therapy + Cetuximab | |
| |prior to registration with surgical pathology demonstrating at least one of the following |Cetuximab initial dose of 400 mg/m2 IV x 1 dose | |
|1 tx credit |“intermediate” risk factors: perineural invasion; lymphovascular invasion; single lymph node > 3| | |
|cc credit |cm or ≥ 2 lymph nodes (all < 6 cm) [no extracapsular extension]; close margin(s) of resection, |Followed at least 5 days later by: | |
| |defined as cancer extending to within 5 mm of a surgical margin; T3 or microscopic T4a primary |Radiation for a total dose of 60 Gy in 30 fractions of 2 | |
| |tumor; T2 oral cavity cancer with > 5 mm depth of invasion. |Gy/day | |
| |Patients must not have prior invasive malignancy (except non-melanomatous skin cancer) unless |Cetuximab 250 mg/m2 IV q week x 6 weeks concur-rently with RT.| |
| |disease free for ≥ 3 years. | | |
| |Patients must not have positive margin(s) [defined as tumor present at the cut or inked edge of | | |
| |the tumor], nodal ex-tracapsular extension, and/or gross residual disease after surgery. |Followed by: | |
| |No prior chemotherapy or anti-EGF therapy, no allergy to cetuximab |Cetuximab 250 mg/m2 IV q week x 4 weeks post–RT. | |
| |Patients must not have had prior RT to the region of the study cancer that would result in | | |
| |overlap of RT fields. | | |
| |Patients must not be eligible for RTOG 0619. | | |
|IRB# 7604: ECOG E1308 A Phase II|Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx as |Induction chemotherapy with Paclitaxel 90mg/m2 on days 1,8, |MBP |
|Trial of Induction Chemotherapy |determined by H&E staining ,newly diagnosed disease,resectable disease OR disease that is |and 15, Cisplatin 75 |Veith |
|Followed by Cetuximab (Erbitux) |expected to become resectable after study treatment, stage III, IVA, or IVB disease as |mg/m2 on day 1, and Cetuximab loading dose of 400 mg/m2 on day|MCLNO –pending |
|with Low Dose vs. Standard Dose |determined by imaging studies (CT scan with IV contrast or MRI required) and a complete head and|1, cycle 1 followed by Cetuximab 250 mg/m2 on days 8 and 15 of|EKL-pending |
|IMRT in Patients with |neck exam |cycle 1 and days 1, 8, and 15 for all subsequent cycles. Doses| |
|HPV-Associated Resectable |Paraffin-embedded tumor specimen available for central confirmation of HPV-associated disease as|will be administered based on actual body | |
|Squamous Cell Carcinoma of the |determined by H&E staining and in-situ hybridization (ISH) for HPV-16 and IHC for p16, |weight. Each cycle will be repeated every 21 days. A total of | |
|Oropharynx |HPV-associated disease is defined as p16 IHC-positive and/or HPV-16 ISH-positive |3 cycles of this | |
| |Measurable disease of the primary tumor or nodes by clinical and radiographic methods, defined |combination will be administered. | |
| |as a lesion that is ≥ 2 cm in at least one dimension by clinical exam AND by radiographic exam | | |
|1rx credit |with CT scan or MRI (or a lesion that is ≥ 1 cm in at least one dimension if the radiographic |Low dose radiation: Cetuximab weekly plus 54.0 Gy/27 fractions| |
| |exam utilizes spiral CT scan) |IMRT | |
| |No primary tumor or nodal metastasis fixed to the carotid artery, skull base, or cervical spine |1. Clinical complete response in primary site. | |
| |No evidence of distant metastases |VS. | |
| |No prior chemotherapy |Standard dose radiation: Cetuximab weekly Plus 69.3 Gy/33 | |
| |No prior radiotherapy above the clavicles |fractions IMRT. | |
| |No prior surgery with curative intent for this disease (complete head and neck exam with biopsy |Patients with any of the following: | |
| |allowed) |1. Clinical partial response or stable disease in primary site| |
| |No prior therapy specifically and directly targeting the EGFR pathway |2. Grossly positive primary site tumor | |
| |ECOG performance status 0-1 | | |
| |Granulocytes ≥ 1,000/mm3 | | |
| |Platelet count ≥ 100,000/mm3 | | |
| |Total serum bilirubin ≤ 1.5 mg/dL | | |
| |Creatinine clearance ≥ 60 mL/min | | |
| |Not pregnant or nursing | | |
| |Negative pregnancy test | | |
| |Fertile patients must use effective contraception | | |
| |No history of another malignancy (except for carcinoma in situ of the cervix and/or | | |
| |nonmelanomatous skin cancer) unless it has been curatively treated and the patient has been | | |
| |disease-free for ≥ 2 years | | |
| |Patients with any of the following within the past 6 months are eligible provided they have been| | |
| |evaluated by a cardiologist and/or neurologist before study entry: | | |
| |NYHA class III-IV congestive heart failure | | |
| |Cerebrovascular accident or transient ischemic attack | | |
| |Unstable angina | | |
| |Myocardial infarction (with or without ST elevation) | | |
| |No uncontrolled diabetes, uncontrolled infection despite antibiotics, or uncontrolled | | |
| |hypertension within the past 30 days | | |
| |No concurrent illness likely to interfere with study therapy or to prevent surgical resection | | |
| |No prior severe infusion reaction to a monoclonal antibody | | |
|LEUKEMIA |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
NONE
|LUNG |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|IRB# 5486: S9925, Lung Cancer |Patients must be enrolled on one of the following SWOG coordinated lung cancer treatment |Lung Cancer Specimen Repository Protocol, Ancillary |MBPCC |
|Specimen Repository Protocol, |protocols: SWOG-8805, SWOG-9019, SWOG-9416, SWOG-9509, S9900, S0003, S0023, S0126, S0124, S0220, | |Veith |
|Ancillary |S0222, S0327, S0310, S0339, S0342, S0341, S0435, S0509, S0429, S0533, S0526 or S0536. Patients | |MOL |
| |subsequently found to be ineligible for the therapeutic protocol to which they are registered will| | |
|Ancillary |be declared ineligible for this protocol. | | |
|0 rx credits | | | |
|0 cc credits | | | |
|IRB#6873C: RTOG (0617), NCCTG |· Patients with histologically or cytologically proven diagnosis of Stage IIIA or Stage IIIB NSCLC|Arms A and C: |MBPCC |
|(N0628), CALGB (30609): A |within 12 weeks of registration. |·Arm C only: Cetuximab loading dose Week 1, then · |EKL |
|Randomized Phase III Comparison |· Patients must be considered unresectable or inoperable. |Chemotherapy (given concurrently with XRT) |CCS |
|Of Standard- Dose (60 Gy) Versus |· There must be no distant metastases. |· Arm C only: Cetuximab q week x 6 weeks |MCLNO |
|High-Dose (74 Gy) Conformal |· Patients must have measurable or evaluable disease. |· Arms A and C: Paclitaxel +Carboplatin q week x 6 weeks | |
|Radiotherapy With Concurrent And |· Patients must be at least 3 weeks from any prior thoracotomy. |·Radiation Therapy (IMRT or 3DCRT) | |
|Consolidation |· Patients must not have N3 supraclavicular disease. |·2 Gy per fraction 5 days a week for 6 weeks | |
|Carboplatin/Paclitaxel +/- |· Patients must not have greater than minimal, exudative, or cytologically positive pleural |· Total dose = 60 Gy in 30 fractions | |
|Cetuximab (Ind #103444) In |effusions (effusions must be proven non-malignant per Section 3.1.4). | | |
|Patients With Stage IIIa/IIIb |· Patients must not have Pancoast tumors. |Arms B and D: | |
|Non-Small Cell Lung Cancer |· Patients must not have involved contralateral hilar nodes (i.e., greater than 1.5 cm on short |·Arm D only: Cetuximab loading dose Week 1, then · | |
| |axis or positive on PET scan). |Chemotherapy (given concurrently with XRT) | |
| |· Patients must not have ≥ 10% weight loss within the past month. |· Arm D only: Cetuximab q week x 7 weeks | |
| |· Patients must not have had prior systemic chemotherapy for the study cancer (prior chemo is |· Arms B and D: Paclitaxel +Carboplatin q week x 7 weeks | |
| |allowed if for a different cancer). |·Radiation Therapy (IMRT or 3DCRT) | |
| |· Patients must not have had prior radiation to the region of the study cancer that would result |· 2 Gy per fraction 5 days a week for 7.5 weeks | |
| |in overlap of radiation therapy fields. |· Total dose = 74 Gy in 37 fractions | |
| | | | |
| | |Following completion of combined therapy: | |
| | |Consolidation chemotherapy: | |
| | |·Arm A: Paclitaxel and Carboplatin Days 64 and 85 | |
| | |·Arm B: Paclitaxel and Carboplatin Days 71 and 92 | |
| | |·Arm C: Paclitaxel and Carboplatin Days 71 and | |
| | |92 | |
| | |Cetuximab Days 50, 57, 64, 71, 78, 85, | |
| | |92, 99, 106 | |
| | |·Arm D: Paclitaxel and Carboplatin Days 78 and | |
| | |99 | |
| | |Cetuximab Days 57, 64, 71, 78, 85, 92, | |
| | |99, 106, 113 | |
|1 rx credit | | | |
|0.5 cc credit | | | |
|IRB#6937C: E1505: A Phase III |· Patients must have undergone complete resection of their NSCLC (stage IB [≥ 4 cm] - IIIA |Arm A: |MBPCC |
|Randomized Trial of Adjuvant |[T2-3N0, T1-3N1, T1-3N2]) prior to enrollment. |· Chemotherapy* |Veith |
|Chemotherapy With or Without |· Patients must have had lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy. |· 4 21-day cycles |MOL |
|Bevacizumab for Patients With |Mediastinal LN sampling must have been done at time of pre-operative mediastinoscopy or |Arm B: |MCLNO |
|Completely Resected Stage IB (> 4|intraoperatively. |· Chemotherapy* |CCS |
|cm) -IIIA Non-Small Cell Lung |· Patients must be ≥ 6 weeks and ≤ 12 weeks post-thoracotomy. |· Bevacizumab 15mg/kg IV Day 1 either before or after | |
|Cancer (NSCLC) |· Patients must not have received prior systemic chemotherapy at any time, or hormonal cancer |chemotherapy | |
| |therapy or radiation therapy as prior cancer treatment within 5 years of randomization. |· 4 21-day cycles | |
| |· Patients must not have any history of CVA or TIA; no symptomatic or uncontrolled CHF or cardiac |· Bevacizumab will then continue for up to a total of one | |
| |arrhythmia. |year (q 21 days) | |
| |· Patients with known history of MI or other evidence of thrombotic disease (angina) must have no | | |
| |evidence of active disease within at least 12 months prior to randomization. |*Chemotherapy Options—Must be chosen prior to randomization| |
| | |· Vinorelbine 30 mg/m2 IV Days 1 and 8 | |
| | |Cisplatin 75 mg/m2 IV Day 1 | |
| | |· Docetaxel 75 mg/m2 IV Day 1 | |
| | |Cisplatin 75 mg/m2 IV Day 1 | |
| | |· Gemcitabine 1200 mg/m2 IV Days 1 and 8 | |
| | |Cisplatin 75 mg/m2 IV Day 1 | |
| | |· Pemetrexed 500 mg/m2 IV Day 1 | |
| | |Cisplatin 75 mg/m2 IV Day 1 | |
|1 rx credit | | | |
| | |Bevacizumab is provided free of charge. | |
|CALGB 30607; Randomized, Phase |histo or cyto stage IIIB/IV NSCLC |sunitinib or placebo |MBPCC |
|III, Double-Blind |no brain mets, spinal compression, carcinomatous meningitis | |Veith |
|Placebo-Controlled Trial of |no cavitary lesions |sunitinib is free of charge |MOL |
|Sunitinib (NSC #736511, IND |must have rec’d 4 cycles of platinum based doublet therapy w/ or w/o bevacizumab | |EKL |
|#74019) as Maintenance Therapy in|no evidence of disease progression | |LKRMC |
|Non-Progressing Patients |no prior adjuvant chemo for stage 1-III resected or combined modality therapy for stage III NSCLC | |MCLNO |
|following an Initial Four Cycles |no other primary therapy for NSCLC | |CCS |
|of Platinum-Based Combination |no CYP3A4 inhibitors or inducers (sect 4.16) | | |
|Chemotherapy in Advanced, Stage |must be able to swallow pills | | |
|IIIB/IV Non-Small Cell Lung |some cardiac restrictions (section 4.7-9) | | |
|Cancer |no bleeding disorders | | |
| | | | |
|1 rx credit | | | |
|0.5 cc credit | | | |
|IRB# 7297C: S0819, "A Randomized,|Patients must have histologically or cytologically proven newly diagnosed Stage IV, advanced |Carboplatin/Paclitaxel or |MBPCC |
|Phase III Study Comparing |primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified)|Carboplatin/Paclitaxel/Bevacizumab |Veith |
|Carboplatin/Paclitaxel or |or recurrent disease after previous surgery and/or irradiation. | |MOL |
|Carboplatin/Paclitaxel/Bevacizuma|Patients with controlled (for a minimum of 2 months) brain metastases after treatment, | |CCS |
|b with or without Concurrent |Patients may have measurable or non-measurable disease (see Section 10.1) documented by CT or MRI.| | |
|Cetuximab in Patients with |Translational Medicine Studies: Patients must agree to submission of specimens for EGFR FISH | |Pending MCLNO |
|Advanced Non-Small Cell Lung |testing and other translational medicine studies as outlined in Section 15.0. Patients must be | | |
|Cancer (NSCLC)" |offered participation in banking for future research. | | |
| |Patients must not have received for any purpose prior chemotherapy, cetuximab, gefitinib, | | |
| |erlotinib or other investigational agents that target the EGFR pathway. Patients must not have | | |
| |received for any purpose prior VEGF-related agents. Patients must not have received for any | | |
| |purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of | | |
| |human anti-mouse antibodies (HAMA). | | |
| |Prior radiation is permitted; however, patients must have recovered from all associated toxicities| | |
| |at time of registration. | | |
| |At least 28 days must have elapsed since surgery | | |
| |Zubrod Performance Status of 0 - 1 ( | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
|1 rx credit | | | |
|IRB# 7239: S0802, "A Randomized |Histologically or cytologically confirmed diagnosis of extensive stage small cell lung cancer | |MBPCC |
|Phase II Trial of Weekly |(E-SCLC) with progression or recurrence after receiving exactly one standard first-line | |Veith |
|Topotecan with and without |platinum-containing regimen. Measurable or non-measurable disease. |Arm 1: AVE0005 plus topotecan |CCS |
|AVE0005 (Aflibercept; NSC-724770)|Brain mets eligible only if has been treated and stable for at least 3 months. No leptomeningeal | |MCLNO |
|in Patients with Platinum Treated|involvement or brain stem mets. |Arm 2: Single-agent topotecan |EKL |
|Extensive Stage Small Cell Lung |At least 21 days since prior RT. | | |
|Cancer (E-SCLC)" |At least 28 days since surgery. | | |
| |No prior bevacizumab or other anti-angiogenic tx. | | |
| |Zubrod PS 0-1. | | |
| |No active infection or bleeding. | | |
| |No uncontrolled hypertension. | | |
| |No history of recent arterial embolic events or congestive heart failure. | | |
| |No significant history of bleeding diathesis including hemoptysis or underlying coagulopathy. | | |
| |No prior history of encephalitis or encephalopathy. No diverticulitis, GI bleeding, or peptic | | |
| |ulcer within prior 3 months. | | |
| |Must be willing to provide smoking history. | | |
| |No known AIDS or HIV-1. | | |
| | | | |
| | | | |
| | | | |
| | | | |
|1 rx credit | | | |
|ECOG 5508 Randomized Phase III |• Patients must have cytological or histological confirmation of NSCLC with predominant |Induction Therapy—Step 1 |MBP |
|Study of Maintenance Therapy with|nonsquamous histology. There must not be small cell elements present. |Paclitaxel 200 mg/m2 IV on Day 1 |Veith |
|Bevacizumab, Pemetrexed, or a |• Patients must have Stage IV (including M1a, M1b stages or recurrent disease). Patients with T4NX|Carboplatin AUC = 6 IV on Day 1 |EKL-pending |
|Combination of Bevacizumab and |disease (stage IIIB) with nodule in ipsilateral lung lobe are eligible as long as they are not |Bevacizumab 15 mg/kg IV on Day 1 |MCLNO-pending |
|Pemetrexed Following Carboplatin,|candidates for combined chemotherapy and radiation. |Give four 21-day cycles | |
|Paclitaxel and Bevacizumab for |• Patients must not have had prior malignancy within the last three years except for superficial | | |
|Advanced Non-Squamous NSCLC |melanoma, basal cell carcinoma, or carcinoma in situ. |*Randomize patients eligible for Step 2* | |
| |• Patients must not have had prior systemic chemotherapy for advanced stage lung cancer. |(Response of stable disease or better per | |
|1rx credit |• Patients may have had prior adjuvant chemotherapy if at least 12 months have elapsed since the |RECIST plus other criteria listed in Section 3.2) | |
| |prior chemotherapy administration. |Maintenance Therapy—Step 2 | |
| |• At least three weeks must have passed since completion of prior radiotherapy. |Arm A: | |
| |• Patients must not have received prior paclitaxel, pemetrexed, or bevacizumab; prior carboplatin |Bevacizumab 15 mg/kg IV on Day 1 | |
| |is allowed if given as part of adjuvant chemotherapy. |Give 21-day cycles until progression or unacceptable | |
| |• Patients must be ≥ 18 years of age with ECOG PS of 0 or 1. |toxicity. | |
| |• Patients must not have brain metastasis. | | |
| |• Patients must not have had major hemoptysis within four weeks prior to registration. |Arm B: | |
| |• Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing |Pemetrexed 500 mg/m2 IV on Day 1 | |
| |or active infection, symptomatic CHF, unstable angina pectoris, serious cardiac arrhythmia, or |Give 21-day cycles until progression or unacceptable | |
| |psychiatric illness/social situations that would limit compliance with study requirements. |toxicity. | |
| |• Patients must have measurable or nonmeasurable disease as defined by RECIST criteria (see | | |
| |Section 6.1.2). |Arm C: | |
| |• Patients with history of HTN must be adequately controlled (PB < 150/100) with appropriate |Pemetrexed 500 mg/m2 IV on Day 1 | |
| |anti-HTN therapy or diet. |Bevacizumab 15 mg/kg IV on Day 1 | |
| |• Patients must not have history of thrombotic events or major bleed within 12 months prior to |Give 21-day cycles until progression or unacceptable | |
| |registration. They must not have had any major surgery, open biopsy or significant traumatic |toxicity. | |
| |injury within 3 months prior to registration, nor a core biopsy within 7 days prior to | | |
| |registration. | | |
| |• Patients may use concomitant anti-coagulation. | | |
| |• Patients must not have significant vascular disease or history of abdominal fistula, GI | | |
| |perforation, or intra-abdominal abscess within six months prior to registration. | | |
| |• Patients must not have clinically significant cardiac disease. | | |
| |• Patients must not have history of non-healing wounds, ulcers, or bone fractures. | | |
| |• Patients must not have cavitary lesions in the lungs. | | |
| |• Patients must not be pregnant or breast feeding; all fertile patients must agree to abstain from| | |
| |sexual intercourse or use adequate contraception during study treatment and ≥ 6 months after. | | |
| |Patients with HIV disease must not be taking anti-retroviral therapy. | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| |· Patients with histologically or cytologically documented small cell lung cancer. |Arm A: |MBPCC |
|CALGB 30610 Phase III Comparison |· Patients must have limited stage disease that is limited to one hemithorax with |Cisplatin/Etoposide* x 4 21-day cycles |CCS |
|of Thoracic Radiotherapy Regimens|regional lymph node metastasis, including ipsilateral hilar, ipsilateral and |Standard Radiation** (starts Day 1 of Cycle 1 or Cycle 2 of| |
|in Patients with Limited Small |contralateral mediastinal, and ipsilateral supraclavicular lymph nodes. |chemo) | |
|Cell Lung Cancer also Receiving |- Patients must not have disease involvement of the contralateral hilar or |45 Gy total dose divided into 1.5 Gy fractions given BID | |
|Cisplatin and Etoposide |supraclavicular lymph nodes, pleural effusions that are visible on plain chest |over 3 weeks (total of 30 fractions) | |
| |radiographs (whether cytologically positive or not), or cytologically positive | | |
| |pleural or pericardial fluid (whether visible plain chest x-ray or not). |Arm B: | |
| |· Patients must have measurable disease, which includes lesions that can be accurately |Cisplatin/Etoposide* x 4 21-day cycles | |
|THERAPEUTIC CREDITS: 1.0 |measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with |Radiation** (starts Day 1 of Cycle 1 or Cycle 2 of chemo) | |
|CANCER CONTROL CREDITS: 0.5 |conventional techniques or as ≥ 1 cm with spiral CT scan. |70 Gy total dose divided into 2.0 Gy fractions given once | |
| |· Patients must not have received any prior radiotherapy or chemotherapy for SCLC. |daily over 7 weeks (total of 35 frac-tions) | |
| |· Patients must not have received any prior mediastinal or thoracic radiotherapy. | | |
| |· Patients must not have had complete surgical resection of disease. |Arm C: | |
| |· Patients must be ≥ 18 years of age; ECOG PS 0-2. |Cisplatin/Etoposide* x 4 21-day cycles | |
| |· Patients must not be known to be pregnant or nursing. |Radiation** (starts Day 1 of Cycle 1 or Cycle 2 of chemo) | |
| |The following are not exclusion criteria, but physicians should recognize that these |61.2 Gy total dose divided into 1.8 Gy fractions given once| |
| |conditions may increase the risk to a patient entering the trial: |daily for 16 days and then BID for 9 days (total of 34 | |
| |· Psychiatric illness that would prevent the patient from giving informed consent. |fractions over 5 weeks) | |
| |· Medical conditions such as uncontrolled infection (including HIV), uncontrolled DM | | |
| |or cardiac disease, which in the opinion of the treating physician would make this |After the accrual of 30 patients per arm, there will be an | |
| |protocol unreasonably hazardous for the patient. |interim analysis. Either Arm B or Arm C will be | |
| |· Patients with “currently active” second malignancy other than non-melanoma skin |discontinued (based on toxicity) at that time and the study| |
| |cancers and carcinoma in situ of the cervix. |will continue with two arms. | |
| |· Women and men of reproductive potential should agree to use an appropriate method |* Cisplatin 80 mg/m2 IV on Day 1 of each cycle | |
| |of birth control throughout their participation in this study. Appropriate methods |Etoposide 100 mg/m2 IV on Days 1-3 of each cycle | |
| |include abstinence, oral contraceptives, implantable hormonal contraceptives, or |** All radiation will be given 5 days a week (i.e., M-F). | |
| |double barrier method. | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
|RTOG 0813 Seamless Phase I/II |Does the patient have a pathologically (histologically or cytologically) proven diagnosis of |Stereotactic body radiation therapy (SBRT) |Pending IGRT approval for|
|Study of Stereotactic Lung |nonsmall cell lung cancer (NSCLC)? | |MBPCC |
|Radiotherapy (SBRT) for Early |Is the patient AJCC stage T1-2, N0, M0, tumor size ≤ 5 cm, prior to registration, based upon the | | |
|Stage, Centrally Located |minimum diagnostic workup specified in Section 3.1? | | |
|Non-Small Cell Lung Cancer |Was a history/physical examination performed within 4 weeks prior to registration? | | |
|(NSCLC) in Medically Inoperable |Was the patient evaluated by an experienced thoracic cancer surgeon within 12 weeks prior to | | |
|Patients |registration? | | |
| |Was the pre-treatment imaging (CT scan with contrast; PET using FDG) done within 8 week prior to | | |
| |registration? | | |
| |Was the Zubrod performance status 0-2 within 4 weeks prior to registration? | | |
| |Is the tumor within or touching the zone of the proximal bronchial tree (as defined in Section | | |
| |3.1.5)? [Note: Tumors that are immediately adjacent to mediastinal or pericardial pleura (PTV | | |
| |touching the pleura) also are considered central tumors and are eligible for this protocol.] | | |
| |Does the patient have measurable disease? | | |
| |Was pleural effusion absent, or, if present, was pleural effusion deemed too small to tap under | | |
| |CT guidance and not evident on chest x-ray? [Note: pleural effusion that appears on chest xray | | |
| |will be permitted only after thoracotomy or other invasive procedure(s).] | | |
| |If female, was there a negative serum or urine pregnancy test performed within 72 hours prior to | | |
| |registration for women of childbearing potential? | | |
| |If the patient is a woman of childbearing potential or a male participant, did the patient agree | | |
| |to use a medically effective means of birth control throughout the patient’s participation in the| | |
| |treatment phase of the study and until at least 60 days following the last study treatment? | | |
| |Did the patient provide study-specific informed consent prior to any protocol-specified | | |
| |procedure(s)? | | |
| |Has the patient had prior invasive malignancy within the past 2 years (other than nonmelanomatous| | |
| |skin cancer) (e.g., carcinomas in situ of the breast, oral cavity, or cervix are permissible)? | | |
| |[Note: previous lung cancer, if the patient is disease-free for a minimum of 2 years is also | | |
| |permitted.] | | |
| |The following questions must be answered NO. | | |
| |Has the patient received prior radiotherapy to the region of the study cancer that would result | | |
| |in overlap of radiation therapy fields? | | |
| |Does the patient plan to receive other local therapy (including standard fractionated | | |
| |radiotherapy and/or surgery) while on this study, except at disease progression? | | |
| |Does the patient plan to receive systemic therapy (including standard chemotherapy or biologic | | |
| |targeted agents) while on this study, except at disease progression? | | |
|LYMPHOMA |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|IRB# 1576: S8947; Central |For patients registered to a currently active Southwest Oncology Group-coordinated treatment |Central Lymphoma Serum Repository Protocol |MBPCC |
|Lymphoma Serum Repository |protocol for previously untreated non-Hodgkin's lymphoma. | | |
|Protocol | | | |
|ANCILLARY | | | |
| | | | |
|0 rx credits | | | |
|0 cc credits | | | |
|MULTIPLE MYELOMA |
|TITLE |ELIGIBILITY |TREATMENT |LOCATION |
|CALGB 70604: A |• Histo confirmed adenocarcinoma of prostate or breast or multiple myeloma |zoledronic acid (every 12 weeks) |MBPCC |
|Randomized, Phase III |At least 1 bone mets confirmed by radiographic imaging |versus |Veith |
|Study of Standard Dosing |No prior IV bisphosphonate tx |zoledronic acid (every 4 weeks) |CCS |
|versus Longer Dosing |No prior radiopharmaceuticals | |LSUHSC |
|Interval of Zoledronic |≥ 4 week since completion of radio-therapy | |MOL |
|Acid in Metastatic Cancer|No current investigational therapy | |MCLNO |
| |No brain mets | | |
|1 cc credit |ECOG status of 0-2 | | |
|S0777: A Randomized |· Patients with newly diagnosed multiple myeloma (MM) with measurable disease. |Arm 1 (LLD): |MBPCC |
|Phase III Trial of |Patients with non-secretory MM will be eligible only if the baseline serum Freelite is elevated. |Dexamethasone 40 mg/day PO Days 1, 8, 15, 22 |CCS |
|CC-5013 (lenalidomide, |· Patients must have received no prior chemotherapy for this disease, nor any prior |Lenalidomide 25 mg/day PO QD Days 1-21 |Veith |
|NSD-703813) and Low Dose |treatment with bortezomib or lenalidomide. They must not have received prior RT to a large area (more |Aspirin 325 mg/day PO QD continuously |MCLNO |
|Dexamethasone (LLD) |than half) of the pelvis. Prior steroid treatment is allowed as long as it was not longer than 2 weeks|Give six 28-day cycles | |
|versus Bortezomib |in duration. | | |
|(PS-341, NSC-681239), |· Patients must be ≥ 18 years of age with Zubrod PS of 0-3 (PS 3 allowed only if MM is the central |Arm 2 (BLLD): | |
|Lenalidomide and Low Dose|cause of the disability). |Dexamethasone 20 mg/day PO Days 1, 2, 4, 5, 8, 9, 11, 12 | |
|Dexamethasone (BLLD) for |· Patients must be offered participation in the Myeloma Specimen Repository for banking and future |Lenalidomide 25 mg/day PO QD Days 1-14 | |
|Induction, in Patients |research (see Section 15.0 for more information). |Bortozomib 1.3 mg/m2 IVP Days 1, 4, 8, 11 | |
|with Previously Untreated|· Sites must submit a local cytogenetics report and FISH analysis report obtained prior to enrollment |Aspirin 325 mg/day QD continuously | |
|Multiple Myeloma without |on S0777. |HSV prophylaxis per institutional standard | |
|an Intent for Immediate |· Patients with pathologic fractures, pneumonia at diagnosis or symptomatic |Give eight 21-day cycles | |
|Autologous Stem Cell |hyperviscosity must have these conditions attended to prior to registration. | | |
|Transplant |· Patients must not have uncontrolled, active infection requiring IV antibiotics, NYHA Class III or IV|Note: Patients who intend to undergo transplant will undergo | |
| |heart failure, MI within the last 6 months, history of treatment for clinically significant |PBSC collection during either Arm 1 or Arm 2 treatment, | |
|THERAPEUTIC CREDITS: 1.0 |ventricular cardiac arrhythmias, poorly controlled HTN, or poorly controlled DM. |preferably after the second cycle. | |
| |· Patients must not have any psychiatric illness that could potentially interfere with the completion |Maintenance Therapy with LLD: | |
| |of treatment according to the protocol. |(begins after ≥ 4 cycles of LLD or ≥ 6 cycles of BLLD) | |
| |· Patients must not have a history of COPD or chronic respiratory pulmonary disease. |Dexamethasone 40 mg/day PO Days 1, 8, 15, 22 | |
| |· Patients must not be Hepatitis B, Hepatitis C, or HIV positive (see Section 5.13 for exception |Lenalidomide 25 mg/day PO QD Days 1-21 | |
| |related to treatment-sensitive HIV disease). |Aspirin 325 mg/day PO QD continuously | |
| |· Patients must not have a history of CVA with persistent neurologic deficits. |Give 28-day cycles until progression | |
| |· Patients must be able to take ASA 325mg daily (or enoxaparin 40 mg SQ daily) as | | |
| |prophylactic anticoagulation (unless already on anticoagulation). | | |
| |· Patients must not be pregnant. Those of both sexes must agree to follow the | | |
| |contraception requirements in Section 5.16 and undergo regular counseling about | | |
| |avoiding pregnancy and having regular pregnancy tests (females). | | |
| |· Patients must not have prior malignancy except for adequately treated BCC or SCC of the skin, in | | |
| |situ cervical cancer, or other cancer for which the patient has been diseasefree for five years. | | |
| |· Patients must be offered participation in GEP molecular studies (see Section 15.2) | | |
PERFORMANCE STATUS SCALES
ZUBROD PERFORMANCE SCALE
0 Fully active, able to carry on all pre-disease activities without restriction.
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work.
2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3 Capable of only limited self-care, confined to bed or chair 50% or more of waking hours.
4 Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
KARNOFSKY PERFORMANCE SCALE
100 Normal; no complaints; no evidence of disease
90 Able to carry on normal activity; minor signs or symptoms of disease
80 Normal activity with effort; some sign or symptoms of disease
70 Cares for self; unable to carry on normal activity or do active work
60 Requires occasional assistance, but is able to care for most personal needs
50 Requires considerable assistance and frequent medical care
40 Disabled; requires special care and assistance
30 Severely disabled; hospitalization is indicated, although death not imminent
20 Very sick; hospitalization necessary; active support treatment is necessary
10 Moribund; fatal processes progressing rapidly
0 Dead
ECOG PERFORMANCE SCALE
0 Fully active, able to carry on all pre-disease performance without restriction
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3 Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4 Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5 Dead
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