ࡱ> x{stuvw bjbjVV <<U8,,::i:i:i:D:::-;=:F5B"WB:BBB>D,ETE,$uXmi:ED">DEE::BBGnWnWnWE :8Bi:BnWEnWnWj:Q:B'h3:R^]0,Ui:nWEEEJV$EEEEEEEEEEEEEEEE, 8:   SEQ CHAPTER \h \r 1xe "CLINICAL TRIALS PERSONNEL:PHYSICIANS" xe "COMBINATION CHEMOTHERAPY ABBREVIATIONS " xe "CLINICAL TRIALS PERSONNEL" 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, Tara504-568-5151 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, Alyce225-215-1206 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 BRAINCCCWFU 91105: Phase III Double Blind, Placebo Controlled Study of Donepezil in Irradiated Brain 1 rx creditLife expectancy of at least > 30 weeks. Must have received a prior course of at least 30 Gy fractionated whole or partial brain irradiation for treatment of a primary brain tumor or metastatic disease to the brain. Must have completed radiation > 6 months prior to enrollment and have no radiographic evidence of brain disease, or stable brain disease defined as no evidence of tumor progression in the 3 months prior to enrollment. 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 completed > 6 months prior to registration if NED or stable disease. Patients who have received PCI (prophylactic cranial irradiation) are eligible. Karnofsky Performance Status must be > 60 or ECOG 0-2. 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.  Arm A: Donepezil tablets x 24 weeks (Week 1-6: one 5 mg tablet per day) (Weeks 7-24: two 5 mg tablets per Arm B: Placebo tablets x 24 weeks (Week 1-6: one tablet per day) (Weeks 7-24: two tablets per day) MBPCC CCS OncologicsBRAINIRB #7591C: RTOG 0825 PHASE III DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF CONVENTIONAL CONCURRENT CHEMORADIATION AND ADJUVANT TEMOZOLOMIDE PLUS BEVACIZUMAB VERSUS CONVENTIONAL CONCURRENT CHEMORADIATION AND ADJUVANT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA THERAPEUTIC CREDITS: 1.0 CANCER CONTROL CREDITS: 0.5  Patients must have histologically proven diagnosis of WHO grade IV glioblastoma or gliosarcoma confirmed by central review prior to step 2 registration. Patients must have tumor tissue that is determined by central pathology review prior to step 2 registration to be adequate for MGMT analysis and determination of molecular profile. Patients tumor must have a supratentorial component. Patients must have recovered from surgery, postoperative infection, and other complications before step 2 registration. Patients must have a diagnostic contrast-enhanced MRI of the brain performed preoperatively and postoperatively prior to initiation of radiotherapy; the postoperative scan must be performed d" 28 days prior to step 1 registration. Patients must have an MRI or CT scan d" 10 days prior to the start of radiation therapy, and it must not demonstrate significant postoperative hemorrhage (defined as > 1 cm diameter of blood). Patients must document steroid doses d" 14 days prior to step 2 registration. Patients must have Karnofsky performance status e" 70. Patients must have systolic blood pressure d" 160 mg Hg or diastolic pressure d" 90 mg Hg within 14 days prior to step 2 registration. Patients who are on full-dose anticoagulation must not have any active bleeding or pathological condition that carries a high-risk of bleeding and must have an in-range INR on a stable dose. 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 e" 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 d" 30 days prior to study entry or during participation in the study. Arm1 = RT + TMZ + placebo Arm2 = RT + TMZ + bevacizumab Initiation of chemoradiation: Radiation 60 Gy in 2 Gy fractions over 6 weeks concurrently with Temozolomide 75 mg/m2 PO QD during radiation course After the first three weeks of chemoradiation, patients are randomized and begin placebo or bevacizumab while continuing chemoradiation Beginning Week 4 of chemoradiation: Placebo or bevacizumab 10 mg/kg IV Days 1 and 15 of each 28-day cycle for 2 doses during chemoradiation and 1 additional dose 2 weeks after the completion of chemoradiation. Beginning 4 weeks after completion of chemo- radiation: Temozolomide 150-200 mg/m2 PO Days 1-5 q 28 days x 6-12 cycles concurrently with Placebo or bevacizumab 10 mg/kg IV Days 1 and 15 q 28 days x 6-12 cycles MBPCC MCLNO- pending BRAINTITLEElIGIBILITYTREATMENTLOCATION ECOG 3F05 Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas THERAPEUTIC CREDITS: 1.0 CANCER CONTROL CREDITS: 0.5 Pre-registration Eligibility: Patients must have pathological diagnosis of astrocytoma grade 2, oligodendroglioma grade 2, or oligoastrocytoma grade 2 (mixed glioma containing astrocytoma and oligodendroglioma). Patients must not have pilocytic astrocytoma, ganglioglioma, pleomorphic xanthastrocytoma, or dysembryoplastic neuroepithelial tumors. The tumors must be supratentorially located. Patients must be e" 18 years of age with Karnofsky PS e" 60%. Patients must have paraffin-embedded tumor specimen available for submission for confirmation of pathological diagnosis and determination of 1p/19q deletion status. Patients must currently have at least one of the following a) uncontrolled symptoms (i.e., HA associated with mass effect, uncontrolled seizures despite two different antiepileptic drug regimens, focal neurological symptoms, cognitive symptoms or deficits), b) tumor progression by serial MRIs (i.e., new or progressive enhancement or new or progressive T2 or FLAIR signal abnormality), or c) age e" 40 years. Patients must be able to undergo MRI with and without contrast. Patients must not have had previous radiation, cytotoxic chemotherapy, radiosurgery, or investigational treatment directed at the brain tumor at any time. There is no limit on the number of previous surgical procedures on this tumor. 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 e" 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 randomizationArm A (Radiation): Radiation* to 5040 cGy in 28 daily fractions of 180 cGy each, given M-F for 5 weeks. Arm B (Radiation + Temozolomide): Radiation* to 5040 cGy in 28 daily fractions of 180 cGy each, given M-F for 5 weeks. Concurrently with TMZ 75 mg/m2 QD during radiotherapy for approximately 5 weeks. Followed approximately 28 days later by TMZ 150** mg/m2 Days 1-5 q 28 days Give a total of 12 28-day cycles * Can be 3D conformal or IMRT. ** If tolerated, dose can be increased to 200 mg/m2 beginning Cycle 2. MBPCC CCS BREASTTITLEELIGIBILITYTREATMENTLOCATIONIRB# 6389: NSABP B-39/RTOG 0413: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer 1 rx credit 0.5 cc credit  Patients must have stage 0, I, or II breast cancer. If stage II, tumor size must be <3 cm. On histological exam, tumor must be DCIS or invasive adenocarcinoma of the breast. Surgical treatment must have been lumpectomy with clean margins (see Sec. 6.1.6). Gross disease must be unifocal with pathologic tumor size <3 cm (see Sec. 6.1.7). Invasive breast cancer requires axillary staging (see Sec 6.1.8). No more than 3 histologically positive axillary nodes, and no positive non-axillary sentinel node(s) are allowed. Must be randomized within 42 days following the last surgery for this breast cancer. ER/PgR analysis must be performed on the primary tumor (see Sec. 6.1.10). Target lumpectomy cavity must be delineated and target reference volume must be <30%. Those with non-breast malignancies are eligible if disease-free for >5 years (see Sec. 6.1.14) Age >18 years; Life expectancy >10 years. All suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, or microcalicifications, densities, or palpable abnormalities must be biopsy-proven negative (see Secs. 6.2.5 and 6.2.6). Group 1: Whole Breast Irradiation (WBI) 45-50 Gy in 25 (1.8-2.0 Gy) fractions to whole breast, followed by optional boost to > 60 Gy Group 2: Partial Breast Irradiation (PBI) 34 Gy in 3.4 Gy fractions using multi-catheter brachytherapy Or 34 Gy in 3.4 Gy fractions using MammoSite balloon catheter Or 38.5 Gy in 3.85 Gy fractions using 3D conformal external beam radiation For all PBI techniques: RT given to index quadrant only, BID (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) ******************************************************* If chemotherapy is to be given (at the discretion of the patients 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.LSUHSC MBPCC CCS OncologicsBREASTTITLEELIGIBILITYTREATMENTLOCATIONNSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy 1 rx creditOnly patients who had a lumpectomy are eligible. Re-excision(s) to achieve tumor-free margins are permitted, but mastectomy is not. Pre-entry central HER2 testing (see Sections 6.1 and 6.2 and Appendix C) is required for all patients. Patients must have an ECOG performance status of 0 or 1 On histologic examination, the tumor must be ductal carcinoma in situ (DCIS). (Patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible.) The DCIS must be HER2-positive as determined by central testing Estrogen and/or progesterone receptor status must be determined prior to randomization. (Patients 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 d" 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. 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.Group 1*: Radiation Therapy Group 2*: Radiation Therapy + Trastuzumab x 2 doses Dose 1: 8 mg/kg IV Dose 2: 6 mg/kg IV given 3 weeks after Dose 1 Trastuzumab will be provided free of charge by Genentech, Inc., and distributed by the NCI Pharmaceutical Management Branch (PMB).MCLNO Veith MOL MBPCC CCS ThibodauxN063D/BIG 2-06, ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study: A randomized, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer 1 rx creditPatients with histologically-confirmed, nonmetastatic, operable primary invasive adenocarcinoma of the breast. Tumor must be adequately excised (see Section 4.2.3.b for exception). Axilla must be dissected; patients must be axillary node positive or node negative with a tumor e" 1.0 cm. Hormone receptor status must be known (ER/PgR or ER alone). Patients must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen (see Section 4.1, Table 5 of the protocol). There must be over expression and/or amplification of HER2 in the invasive component of the primary tumor which must be confirmed by the central laboratory prior to randomization. Patients must not have a history of any prior (ipsi and/or contralateral) invasive breast carcinoma. Patients must not have bilateral tumors. Patients must not have a clinically staged T4 tumor, including inflammatory breast cancer. Patients must not have had (neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support. Patients must not have had any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer. Patients must not have positive or suspicious internal mammary nodes identified by sentinel node technique which will have not been irradiated or will not be irradiated, nor supraclavicular lymph 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. Patients must not have concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer.Treatment Plan See Section 5.0 for Complete Treatment Details Design 2 Trastuzumab Arm Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Trastuzumab 2mg/kg* IV q 7 days x 12 weeks, followed by Trastuzumab 6mg/kg IV q 21 days x 40 weeks Lapatinib Arm Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Lapatinib 1500 mg PO QD x 52 weeks Trastuzumab followed by Lapatinib Arm Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Trastuzumab 2 mg/kg* IV q 7 days x 12 weeks 6-week washout, followed by Lapatinib 1500 mg PO QD x 34 weeks Lapatinib combined with Trastuzumab Arm Paclitaxel 80 mg/m2 IV q 7 days x 12 weeks, with Lapatinib 750 mg PO QD x 12 weeks, and Trastuzumab 2mg/kg* IV q 7 days x 12 weeks, followed by Lapatinib 1000 mg PO QD x 40 weeks, with Trastuzumab 6mg/kg IV q 21 days x 40 weeks * A loading dose of trastuzumab is given on Day 1that is 2 mg/kg higher than the regular dose shown here.MCLNO Veith MOL MBPCC EKL CCS CALGB 70604: A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer 1 cc credit  Histo confirmed adenocarcinoma of prostate or breast or multiple myloma At least 1 bone mets confirmed by radiographic imaging No prior IV bisphosphonate tx No prior radiopharmaceuticals e" 4 week since completion of radio-therapy No current investigational therapy No brain mets ECOG status of 0-2zoledronic acid (every 12 weeks) versus zoledronic acid (every 4 weeks) MBPCC Veith CCS LSUHSC MOL MCLNO IRB# 7310: Z1071: A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis 1 rx creditECOG/Zubrod Performance Status 0-1 Histologic diagnosis of invasive breast cancer, clinical stage T1-4 N1-2 (excluding inflammatory breast cancer). FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy. Preoperative chemotherapy must be completed or planned for patient. Non-pregnant and non-lactating (breast feeding). No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.Surgery followed by chemoMBPCC Veith CCS LSUHSC MOL MCLNO CALGB 40503 Endocrine Therapy in Combination with ANTI-VEGF Therapy: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptorpositive Advanced Breast Cancer rx credit Patients must be women with histologic confirmation of invasive cancer of the breast in either primary or metastatic setting; It must be Stage IV disease or Stage IIIB disease not amenable to local therapy. Tumors must be either ER and/or PgR positive. Patients may be postmenopausal (per criteria in Section 4.5.2) or must undergo ovarian suppression (per Section 8.3) starting prior to or on day 1 of protocol therapy. Patients must have measurable or non-measurable disease by RECIST criteria (per Section 4.6). Patients may not have had prior endocrine therapy in the metastatic setting, unless tamoxifen or an AI was started within 4 weeks prior to registration to facilitate the enrollment of patients who recently started 1st-line endocrine therapy for metastatic 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 metastatic setting (see Section 7.7.1). Patients may not have had any prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy. Any prior RT must have been completed and all toxicities resolved at least two weeks prior to registration. 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.Arm I: Endocrine therapy* Bevacizumab 15 mg/kg IV q 21days Ovarian suppression if required# Continue until progressive disease Arm II: Endocrine therapy* Ovarian suppression if required# Continue until progressive disease *The choice of endocrine therapy (letrozole or tamoxifen) is up to the treating physician (see Section 8.3 for recommendations). # Ovarian suppression for premenopausal women must be medical or surgical (not via radiation). See Section 8.4 for choices of LHRH agonists. MBPCC CCS Veith EKL- pending MCLNO- pending CANCER CONTROLTITLEELIGIBILITYTREATMENTLOCATIONSee specific disease site for current cancer control studies.  GASTROINTESTINALTITLEELIGIBILITYTREATMENTLOCATIONIRB# 6736: SWOG C80405: A Phase III Trial Of Irinotecan/5-Fu/Leucovorin Or Oxaliplatin/5-Fu/Leucovorin With Bevacizumab, Or Cetuximab (C225), Or With The Combination Of Bevacizumab And Cetuximab For Patients With Untreated Metastatic Adenocarcinoma Of The Colon Or Rectum 1 rx credit Patients with histologically or cytologically documented locally advanced or metastatic adenocarcinoma of the colon or rectum that has not been resected. Patients may have a history of colorectal cancer treated by surgical resection and now have evidence of metastatic cancer. Patients must have a wildtype K-ras gene as determined by the SWOG Solid Tumor Repository. Patients may not have received any prior systemic treatment for advanced or metastatic disease, but may have received prior adjuvant chemo that concluded > 12 months prior to registration or prior neoadjuvent chemo-radiation with capecitabine or 5-FU. No prior exposure to agents that target VGEF or EGF receptors; no prior exposure to bevacizumab or Cetuximab. 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 Gilberts Syndrome or be known to be homozygous for the UGT1A1*28 allele, and those to receive FOLFOX may not have sensory peripheral neuropathy of > grade 2 at baseline.Arm A: Bevacizumab 5mg/kg IV q 2 weeks FOLFOX/FOLFIRI* q 2 weeks 1 cycle = 8 weeks Arm B Cetuximab 400mg/m2 IV on Day 1, then Cetuximab 250mg/m2 IV Weekly thereafter FOLFOX/FOLFIRI* q 2 weeks 1 cycle = 8 weeks *The decision to use FOLFOX or FOLFIRI is at the patient/treating physician s discretion (while complying with eligibility criteria 4.5 and 4.6). Cetuximab is provided free of chargeLSU MBPCC Med Onc EKL MCLNO CCS E3205: Phase II Trial of Cetuximab Plus Cisplatin, 5-Fluorouracil and Radiation in Immunocompetent Patients with Anal Carcinoma 1 rx credit histologically proven stage I-IIIB invasive anal canal or perianal (anal margin) squamous cell carcinoma must be > 18 years ECOG performance status of 0-2 No concurrent malignancies no history of prior radiation or chemotherapy for this malignancy 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 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 Cetuximab Plus Cisplatin, 5-Fluorouracil and Radiation Cetuximab is provided free of chargeMBPCC Med Onc Veith MCLNO EKL CCSCALGB 80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer 1 tx credit Documented adenocarcinoma of the colon and at least one pathologically confirmed positive lymph node. Patients must not have rectal cancer (i.e., the tumor must be at least 12 cm from the anal verge). Patients must have had complete resection of the tumors; if tumor is adherent to adjacent structures, patients must have documentation of en bloc R0 resection. Patients must not have any evidence of residual involved lymph node disease or metastatic disease at the time of registration. Patients may have synchronous colon cancers, but must not have synchronous colon and rectal primary tumors. Patients must not use NSAIDs at any dose or aspirin at > 325 mg more than two times per week on average (low dose aspirin, d" 100 mg/day is permitted). 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 carcinoma in situ in one breast, or any other cancer for which the patient has been disease free for e" 5 years. Patients must not have neurosensory or neuromotor toxicity e" grade 2 at time of registration. Patients must not have known allergy to platinum compounds, or prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs. 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 e" 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. Treatment must begin between 21 and 56 days after definitive surgical resection of primary tumor and within 14 days of randomization. One cycle = 14 days of treatment Medications: FOLFOX: Oxaliplatin 85 mg/m2 IV over 2 hours followed by Leucovorin 400 mg/m2 IV over 2 hours (may be administered concurrently via separate infusion lines) followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 con-tinuous IV infusion over 46-48 hours. Celecoxib: 400 mg daily PO Arm A: 12 cycles of FOLFOX + Placebo daily Arm B: 12 cycles of FOLFOX + Celecoxib daily Arm C: 6 cycles of FOLFOX + Placebo daily Arm D: 6 cycles of FOLFOX + Celecoxib daily Celecoxib/placebo will continue for 3 years or until unacceptable toxicity.EKL MBP CCS Veith MCLNONSABP PROTOCOL P-5 Statin Polyp Prevention Trial in Patients with Resected Colon Cancer 1cc creditSelected eligibility criteria: Resected adenocarcinoma of the colon staged as AJCC StageI or II Surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to randomization (laparoscopicallyassisted colectomy is permitted) Patients must > 18 years old Adjuvant therapy, if given, must be completed before randomization Patients taking cardioprotective low-dose aspirin must be able and willing to continue at the same dose Colonoscopy (preop or postop) to the cecum or small bowel anastomosis with removal of all observed polyps within 180 days prior to randomization Within 90 days prior to randomization: o Serum creatinine must be < 1.5 x ULN o AST or ALT < 3.0 x ULN and total bilirubin must be < 1.5 x ULN (If AST & ALT obtained, both must be < 3.0 x ULN) Selected ineligibility criteria: Tumor with the distal border located <12 cm from the anal verge Total colectomy or total proctocolectomy Classic Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis, or Hereditary Nonpolyposis Colorectal Cancer (Lynch Syndrome) Statin use within 30 days prior to randomization Hyperlipidemia with clinical indication for statin therapy Chronic use of therapeutic aspirin (doses > 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 P-5 study therapy Each patient will take 1 tablet of the P-5 study drug once daily for 5 years. Patients will take either: " rosuvastatin 10 mg (one tablet) orally without regard to meals, once a day for 5 years, or " placebo (one tablet) orally without regard to meals, once a day for 5 years. This is a double-blind trial. Neither the patient nor the investigator/health care providers will know the treatment assignment until the completion of the trial.MBP EKL CCS Veith MCLNOIRB # 7647C: CALGB 80802 Phase III randomized study of sorafenib (IND 69896, NSC 724772) plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC) THERAPEUTIC CREDITS: 1.7 TOTAL (1.0 for 80802 study; 0.3 for 150902 Ancillary; 0.3 for 580901 Ancillary; 0.1 for 60901 Ancillary) CANCER CONTROL CREDITS: 0  pathologically or cytologically proven HCC. Known mixed histology or fibrolamellar variant is not allowed. The disease must be locally advanced or metastatic. Locally advanced disease is defined as disease deemed to be unresectable or non-eligible for transplant without distant metastases. Patients must have measurable disease that is accurately measurable in at least one dimension as e" 2 cm with conventional techniques or e" 1 cm with spiral CT scan. Patents must not have had prior adjuvant sorafenib or other Raf/VEGF inhibitors. Other prior adjuvant therapy is allowed if completed > 6 months prior to study entry with documented recurrence of HCC. Patients may have had prior locoregional therapies such as embolization, chemo-embolization (except with doxorubicin), radiation, radioactive microspheres, etc., provided that they either have a target lesion that has not been subjected to local therapy and/or the target lesion(s) within the field has shown an increase of e" 25% in size since last treatment. Such therapy must be completed e" 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 e" 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 e" 4 weeks from study entry. Patients must not be taking concomitant treatment with Rifampin or St. John s Wort; these drugs should be discontinued e" 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 e" 18 years of age with ECOG PS of 0-2. Arm A: Doxorubicin 60 mg/m2 IV Day 1 May give G-CSF x three days or GM-CSF x one day after each doxorubicin dose Sorafenib 400 mg PO BID QD Give six 21-days cycles of doxorubicin and sorafenib, and then continue sorafenib until unacceptable toxicity or disease progression. Arm B: Sorafenib 400 mg PO BID QD Continue sorafenib until unacceptable toxicity or disease progression. MBPCC CCS Veith EKL- pending MCLNO- pendingNCCTG N08CB A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity CANCER CONTROL CREDITS: 1.0 Histologically confirmed adenocarcinoma of the colon or rectum. Has undergone curative resection and is considered to have stage II orstage III disease or completely resected stage IV disease with no evidence of residual tumor. Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy with 85 mg/m2 oxaliplatin every 2 weeks. This includes, for instance, FOLFOX4 or modified FOLFOX Note: Adjuvant FOLFOX can be conducted with or without bolus 5FU. Definitions FOLFOX4: 2-hour infusion of LV (200 mg/m2/d) with oxaliplatin 85 mg/m2 as a 2-hour infusion on day 1; followed by a 5FU bolus (400 mg/m2/d) and 22-hour infusion (600 mg/m2/d) for 2 consecutive days every 2 weeks MODIFIED FOLFOX6: 2-hour infusion of LV (400 mg/m2) with oxaliplatin 85 mg/m2 as a 2-hour 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 d"28 days prior to registration: WBC e"3000, ANC e"1500, PLT e"100,000, HgB e"10.0, Total bilirubin d"1.5 x upper normal limit (UNL), Serum creatinine d"1.5 x UNL, Serum calcium d" 1.2 x UNL, Serum magnesium d" 1.2 x UNL Negative pregnancy test (serum or urine) done d" 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. Calcium gluconate plus magnesium sulfate 1 g of each agent IV in 100 ml D5W over 30 minutes immediately before and after each oxaliplatin administration Placebo 100 ml bag of D5W IV over 30 minutes immediately before and after each oxaliplatin administration Calcium gluconate plus magnesium sulfate 1 g of each agent in 100 ml bag of D5W IV over 30 minutes Immediately before each oxaliplatin administration PlaceboImmediately after each oxaliplatin administration Veith MCLNO ECOG E7208  TITLE \* MERGEFORMAT A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab, in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy 1Tx creditHistologically documented adenocarcinoma (including the histologic variants of adenocarcinoma) of the colon or rectum.Patients K-ras status must be wild type (not mutated). K-ras status determination may bebased on either primary or metastatic tumor. Patients must have had prior first-line therapy with oxaliplatin-based fluoropyrimidinecontaining chemotherapy and bevacizumab for metastatic colorectal cancer. Registration within 42 days of documented disease progression. Registration within 90 and no fewer than 28 days of last dose of bevacizumab. Performance Status 0-1. Adequate Organ Function < 4 weeks prior to registration. Hematologic: Absolute neutrophil count (ANC) e" 1500/L, hemoglobin e" 9 g/dL, and platelets e" 75,000/L. Renal: Serum creatinine d" 1.5 x the ULN, or creatinine clearance (measured via 24- hour urine collection) e" 40 mL/minute. Proteinuria: Urinary protein d" 1+ on dipstick or routine urinalysis (UA); if urine dipstick or routine analysis is e" 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 d" 2.0 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) d" 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) d" 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 d" 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.Treatment/ARM A Cetuximab 500 mg/m2 IV q 14 days Irinotecan 180 mg/m2 IV over 60-90 minutes q 14 days Repeat cycles every 14 days until progression. Treatment/ARM B Ramucirumab 8 mg/kg IV over 60 minutes q 14 days. The dose of ramucirumab is to be recalculated should the patients weight change by 10% Cetuximab 500 mg/m2 IV q 14 days Irinotecan 180 mg/m2 IV over 60-90 minutes q 14 days Ramucirumab should be given first, followed by cetuximab and then irinotecan. Repeat cycles every 14 days until progression. MBPCC CCS EKL-pending Veith MCLNO- pending GENITOURINARYTITLEELIGIBILITYTREATMENTLOCATIONR0534: A Phase III Trial Of Short-term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed-Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy 1.5 rx credits Patients must have adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be LN negative by pelvic lymphadenopathy (pN0) or LN status pathologically unknown (undissected pelvic LNs [pNx]) Post-prostatectomy PSA of e" 0.1 and < 2.0 ng/mL Disease must be pathologic T3N0/Nx or pathologic T2N0/Nx with or without a positive prostatectomy margin. There must be no distant metastases. Patients must not have a palpable prostatic fossa abnormality or mass suggestive of recurrence, unless it has been shown by biopsy under US guidance not to contain cancer. Patients must not have N1 disease or pelvic LN enlargement e" 1.5 cm in greatest dimension by CT or MRI of the pelvis (unless proven negative by biopsy). Patients must not have received androgen deprivation therapy that was started prior to prostatectomy for > 6 months duration. Patients must not have received androgen deprivation therapy that was started after prostatectomy and prior to registration. Patients must not have had prior pelvic radiotherapy. Arm 1: PBRT alone RT to prostate bed to 64.8-70.2 Gy Arm 2: PRBT plus NC-STAD LHRH agonist injections to cover 4-6 months E.g., leuprolide, goserelin, triptorelin Antiandrogen for 4-6 months Flutamide or bicalutamide RT to prostate bed to 64.8-70.2 Gy beginning 2 months after start of drug therapy Arm 3: PLNRT plus PBRT plus NC-STAD LHRH agonist injections to cover 4-6 months E.g., leuprolide, goserelin, triptorelin Antiandrogen for 4-6 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 PBRT = prostate bed radiation therapy PLNRT = pelvic lymph node radiation therapy NC-STAD = neoadjuvent and concurrent short term androgen deprivation.MBPCC CCS GENTOURINARYTITLEELIGIBILITYTREATMENTLOCATIONCALGB-90202: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone 1 rx creditHistologic documentation of prostate adenocarcinoma (see sec 5.1) At least one bone metastasis by radiographic imaging (see sec 5.2) Patients must receive androgen deprivation therapy for treatment of prostate CA (see sec 5.3) Hormone therapy (HT) at any point prior to 6 mos before enrollment is prohibited (see sec 5.4) Prior neoadjuvant and/or adjuvant HT is allowed provided that the duration of HT was < 6 mos and HT was discontinued > 6 mos prior to study entry No prior treatment with a bisphosphonate or with radiopharmaceuticals e" 4 wks since completion of prior RT ECOG (CTC) performance status 0-2Double-Blinded Zoledronic acid: 4 mg IV Q 4 wks or Placebo: IV Q 4 wks Patients who experience PD* during the double blind portion: Open label Zoledronic acid 4 mg IV Q 3 wks Patient who experience an SRE** at any time during the study: End protocol treatment *PD: Progressive disease **SRE: Skeletal-related eventMBPCC LSUHSC Veith MOL CCS MCLNOCALGB 70604: A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer 1 cc credit " Histo confirmed adenocarcinoma of prostate or breast or MM At least 1 bone mets confirmed by radiographic imaging No prior IV bisphosphonate tx No prior radiopharmaceuticals e" 4 week since completion of radio-therapy No current investigational therapy No brain mets ECOG status of 0-1 zoledronic acid (every 12 weeks) versus zoledronic acid (every 4 weeks) MBPCC Veith CCS LSUHSC MOL MCLNOGENTOURINARYTITLEELIGIBILTIYTREATMENTLOCATIONCALGB 90601: A Randomized Double Blind Phase III Study comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, cisplatin and Placebo in Patients with Advanced Transitional Cell Carcinoma 1rx creditHistologically documented metastatic or unresectable transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra), with progressive metastatic or locally advanced disease. Patients must not be candidates for potentially curative surgery or radiotherapy. Patients may not have received combination systemic chemotherapy for metastatic disease. For the purposes of this study, radiosensitizng single agent chemotherapy is not considered prior systemic therapy. Prior neoadjuvant or adjuvant systemic chemotherapy is permissible provided the interval from end of therapy to diagnosis of metastatic diseases is at least 1 year. > 4 weeks since any intavesical therapy 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 0-1Gemcitabine 1000mg/m2 IV on Day 1 and Day 8of every cycle, Cisplatin 70mg/m2 IV on Day 1 and Placebo 15mg/kg Iv on Day 1 every 21 days for 6 cycles then placebo 15mg/kg Iv every 21 days Versus Gemcitabine 1000mg/m2 IV on Day 1 and Day 8 of every cycle, cisplatin 70mg/m2 IV on Day 1, and Bevacizumab 15mg/kg IV on Day 1 Then Bevacizumab 15mf/kg IV every 21 days Veith MBPCC CCSIRB #7627 CCCWFU 98110: A Randomized Phase II Dose Finding Study of ArginMax for Its Effect on Erectile Function and Quality of Life in Survivors of Prostate Cancer Previously Treated with Radiotherapy 1cc creditMale prostate cancer survivor previously treated with radiotherapy and who identifies himself as concerned with sexual quality of life, including erectile dysfunction. Patient must describe himself as having had successful sexual activity prior to the commencement of radiotherapy. Must be interested in sexual activity, and agree to make at least one sexual intercourse attempt every week during the study. The use of PDE-5 inhibitors will be a voluntary component of the trial and will serve as a 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 (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. ArginMax at one of three dose levels: Arm 1: 6 capsules placebo bid Arm 2: 3 capsules ArginMax & 3 capsules placebo BID Arm 3: 6 capsules ArginMax bid All patients will take the assigned medications twice daily. Pill diaries will be provided. All patients will take the same number of pills daily.MBPCC Veith CCS CALGB 90203: Randomized Phase III Study Of Neo-Adjuvant Docetaxel And Androgen Deprivation Prior To Radical Prostatectomy Versus Immediate Radical Prostatectomy In Patients With High-Risk, Clinically Localized Prostate Cancer 1.5 rx credits Histologic documentation of prostate adenocarcinoma (no small cell, neuroendocrine, or transition cell allowed). Must have known Gleason sum by biopsy or TURP at registration. Clinical stage T1-T3a and no radiographic evidence of metastatic disease. Deemed high risk by either a) Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60% or b) prostate biopsy Gleason sum e" 8. No prior treatment for prostate cancer, including surgery (except TURP), LN dissection, radiation, or chemotherapy. May have received up to 3 months of androgen deprivation therapy. Must be appropriate candidate for radical prostatectomy with life expectancy of > 10 years as determined by a urologist. Age > 18 years; ECOG PS 0-1  Arm A: Docetaxel 75 mg/m2 IV Day 1q 21 days x 6 cycles Concurrently with LHRH agonist x 18-24 weeks Followed within 60 days by Staging pelvic lymphadenectomy Radical Prostatectomy* Arm B: Staging pelvic lymphadenectomy Radical Prostatectomy* Docetaxel supplied free of chargeMBPCC LSUHSC Veith MOL MCLNO  RTOG 0436 A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery THERAPEUTIC CREDITS: 1.0 CANCER CONTROL CREDITS: 0.5  Patients must have a histologically proven diagnosis (via endoscopy or FNA) of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks of registration. All disease must be encompassed in the radiotherapy field. Patients may have celiac, perigastric, mediastinal, or supraclavicular adenopathy. Patients may have cervical esophageal carcinoma. Disease must be T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a based on diagnostic workup in Section 3.1.2. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula; patients must not have evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi. Patients must be e" 18 and < 75 years of age with Zubrod PS 0-2. Patients must have a total intake (oral/enteral) of e" 1500 kCal/day. 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.Arm 1: Radiation 180 cGy/fx on Days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 (total of 50.4 Gy) Cetuximab 400 mg/m2 IV on Day 1 Cetuximab 250 mg/m2 IV on Days 8, 15, 22, 29, and 36 Paclitaxel 50 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 Cisplatin 25 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 Arm 2: Radiation 180 cGy/fx on Days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 (total of 50.4 Gy) Paclitaxel 50 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 Cisplatin 25 mg/m2 IV on Days 1, 8, 15, 22, 29, and 36 Pending facility questionnaire for MBPCC HEAD AND NECKTITLEELIGIBILITYTREATMENTLOCATION E1305: A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer 1 rx creditHistologically or cytologically confirmed SCCHN, from any primary site that is either (a) recurrent, judged incurable by surgery or radiation or (b) metastatic. No prior chemotherapy or biologic/molecular targeted therapy for recurrent or metastatic SCCHN. No prior bevacizumab, ECOG performance status of 0-1 Previous palliative radiotherapy to the head and neck is allowed if a minimum of 8 weeks has elapsed between the end of prior radiotherapy and entry into the protocol. No prior reirradiation in the head and neck region is allowed. A minimum of 3 weeks must elapse between 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 can be made).Arm A: Cisplatin plus Docetaxel OR Cisplatin plus 5-FU. Vs. Arm B: Docetaxel plus Cisplatin plus Bevacizumab OR Cisplatin plus Bevacizumab plus 5-FU.MBPCC LSUHSC Veith MOL MCLNO CCS EKLRTOG 0920: A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER 1 tx credit cc creditHistologically proven squamous cell carcinoma of the head/neck (oral cavity, oropharynx or larynx; hypopharynx primaries not allowed). No simultaneous primaries or bilateral tumors. clinical stage T1, N1-2 or T2-3, N0-2, M0 including no distant metastases d" 8 weeks of registration. Patients must have had gross total resection of primary tumor with curative intent d" 7 weeks prior to registration with surgical pathology demonstrating at least one of the following  intermediate risk factors: perineural invasion; lymphovascular invasion; single lymph node > 3 cm or e" 2 lymph nodes (all < 6 cm) [no extracapsular extension]; close margin(s) of resection, defined as cancer extending to within 5 mm of a surgical margin; T3 or microscopic T4a primary tumor; T2 oral cavity cancer with > 5 mm depth of invasion. Patients must not have prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for e" 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. No prior chemotherapy or anti-EGF therapy, no allergy to cetuximab 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.Arm 1: Radiation Therapy Radiation for a total dose of 60 Gy in 30 fractions of 2 Gy/day Arm 2: Radiation Therapy + Cetuximab Cetuximab initial dose of 400 mg/m2 IV x 1 dose Followed at least 5 days later by: Radiation for a total dose of 60 Gy in 30 fractions of 2 Gy/day Cetuximab 250 mg/m2 IV q week x 6 weeks concur-rently with RT. Followed by: Cetuximab 250 mg/m2 IV q week x 4 weeks postRT. EKL MBP CCS MCLNO -pendingIRB# 7604: ECOG E1308 A Phase II Trial of Induction Chemotherapy Followed by Cetuximab (Erbitux) with Low Dose vs. Standard Dose IMRT in Patients with HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx 1rx creditHistologically or cytologically confirmed squamous cell carcinoma of the oropharynx as determined by H&E staining ,newly diagnosed disease,resectable disease OR disease that is expected to become resectable after study treatment, stage III, IVA, or IVB disease as determined by imaging studies (CT scan with IV contrast or MRI required) and a complete head and neck exam Paraffin-embedded tumor specimen available for central confirmation of HPV-associated disease as determined by H&E staining and in-situ hybridization (ISH) for HPV-16 and IHC for p16, HPV-associated disease is defined as p16 IHC-positive and/or HPV-16 ISH-positive Measurable disease of the primary tumor or nodes by clinical and radiographic methods, defined as a lesion that is e" 2 cm in at least one dimension by clinical exam AND by radiographic exam with CT scan or MRI (or a lesion that is e" 1 cm in at least one dimension if the radiographic exam utilizes spiral CT scan) No primary tumor or nodal metastasis fixed to the carotid artery, skull base, or cervical spine No evidence of distant metastases No prior chemotherapy No prior radiotherapy above the clavicles No prior surgery with curative intent for this disease (complete head and neck exam with biopsy allowed) No prior therapy specifically and directly targeting the EGFR pathway ECOG performance status 0-1 Granulocytes e" 1,000/mm3 Platelet count e" 100,000/mm3 Total serum bilirubin d" 1.5 mg/dL Creatinine clearance e" 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 e" 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 Induction chemotherapy with Paclitaxel 90mg/m2 on days 1,8, and 15, Cisplatin 75 mg/m2 on day 1, and Cetuximab loading dose of 400 mg/m2 on day 1, cycle 1 followed by Cetuximab 250 mg/m2 on days 8 and 15 of cycle 1 and days 1, 8, and 15 for all subsequent cycles. Doses will be administered based on actual body weight. Each cycle will be repeated every 21 days. A total of 3 cycles of this combination will be administered. Low dose radiation: Cetuximab weekly plus 54.0 Gy/27 fractions IMRT 1. Clinical complete response in primary site. VS. Standard dose radiation: Cetuximab weekly Plus 69.3 Gy/33 fractions IMRT. Patients with any of the following: 1. Clinical partial response or stable disease in primary site 2. Grossly positive primary site tumorMBP Veith MCLNO pending EKL-pending LEUKEMIATITLEELIGIBILITYTREATMENTLOCATIONNONE LUNGTITLEELIGIBILITYTREATMENTLOCATIONIRB# 5486: S9925, Lung Cancer Specimen Repository Protocol, Ancillary Ancillary 0 rx credits 0 cc creditsPatients must be enrolled on one of the following SWOG coordinated lung cancer treatment protocols: SWOG-8805, SWOG-9019, SWOG-9416, SWOG-9509, S9900, S0003, S0023, S0126, S0124, S0220, S0222, S0327, S0310, S0339, S0342, S0341, S0435, S0509, S0429, S0533, S0526 or S0536. Patients subsequently found to be ineligible for the therapeutic protocol to which they are registered will be declared ineligible for this protocol.Lung Cancer Specimen Repository Protocol, AncillaryMBPCC Veith MOLIRB#6873C: RTOG (0617), NCCTG (N0628), CALGB (30609): A Randomized Phase III Comparison Of Standard- Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent And Consolidation Carboplatin/Paclitaxel +/- Cetuximab (Ind #103444) In Patients With Stage IIIa/IIIb Non-Small Cell Lung Cancer 1 rx credit 0.5 cc credit Patients with histologically or cytologically proven diagnosis of Stage IIIA or Stage IIIB NSCLC within 12 weeks of registration. Patients must be considered unresectable or inoperable. There must be no distant metastases. Patients must have measurable or evaluable disease. Patients must be at least 3 weeks from any prior thoracotomy. Patients must not have N3 supraclavicular disease. Patients must not have greater than minimal, exudative, or cytologically positive pleural effusions (effusions must be proven non-malignant per Section 3.1.4). Patients must not have Pancoast tumors. Patients must not have involved contralateral hilar nodes (i.e., greater than 1.5 cm on short axis or positive on PET scan). Patients must not have e" 10% weight loss within the past month. Patients must not have had prior systemic chemotherapy for the study cancer (prior chemo is allowed if for a different cancer). Patients must not have had prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.Arms A and C: Arm C only: Cetuximab loading dose Week 1, then Chemotherapy (given concurrently with XRT) Arm C only: Cetuximab q week x 6 weeks Arms A and C: Paclitaxel +Carboplatin q week x 6 weeks Radiation Therapy (IMRT or 3DCRT) 2 Gy per fraction 5 days a week for 6 weeks Total dose = 60 Gy in 30 fractions Arms B and D: Arm D only: Cetuximab loading dose Week 1, then Chemotherapy (given concurrently with XRT) Arm D only: Cetuximab q week x 7 weeks Arms B and D: Paclitaxel +Carboplatin q week x 7 weeks Radiation Therapy (IMRT or 3DCRT) 2 Gy per fraction 5 days a week for 7.5 weeks 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, 113MBPCC EKL CCS MCLNOIRB#6937C: E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC) 1 rx credit Patients must have undergone complete resection of their NSCLC (stage IB [e" 4 cm] - IIIA [T2-3N0, T1-3N1, T1-3N2]) prior to enrollment. Patients must have had lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy. Mediastinal LN sampling must have been done at time of pre-operative mediastinoscopy or intraoperatively. Patients must be e" 6 weeks and d" 12 weeks post-thoracotomy. Patients must not have received prior systemic chemotherapy at any time, or hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. Patients must not have any history of CVA or TIA; no symptomatic or uncontrolled CHF or cardiac arrhythmia. 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Patients with controlled (for a minimum of 2 months) brain metastases after treatment, Patients may have measurable or non-measurable disease (see Section 10.1) documented by CT or MRI. Translational Medicine Studies: Patients must agree to submission of specimens for EGFR FISH testing and other translational medicine studies as outlined in Section 15.0. Patients must be 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 (Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/BevacizumabMBPCC Veith MOL CCS Pending MCLNOIRB# 7239: S0802, "A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)" 1 rx creditHistologically or cytologically confirmed diagnosis of extensive stage small cell lung cancer (E-SCLC) with progression or recurrence after receiving exactly one standard first-line platinum-containing regimen. Measurable or non-measurable disease. Brain mets eligible only if has been treated and stable for at least 3 months. No leptomeningeal involvement or brain stem mets. At least 21 days since prior RT. 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.  Arm 1: AVE0005 plus topotecan Arm 2: Single-agent topotecan MBPCC Veith CCS MCLNO EKL ECOG 5508 Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC 1rx credit  Patients must have cytological or histological confirmation of NSCLC with predominant nonsquamous histology. There must not be small cell elements present. Patients must have Stage IV (including M1a, M1b stages or recurrent disease). Patients with T4NX disease (stage IIIB) with nodule in ipsilateral lung lobe are eligible as long as they are not candidates for combined chemotherapy and radiation. Patients must not have had prior malignancy within the last three years except for superficial melanoma, basal cell carcinoma, or carcinoma in situ. Patients must not have had prior systemic chemotherapy for advanced stage lung cancer. Patients may have had prior adjuvant chemotherapy if at least 12 months have elapsed since the prior chemotherapy administration. At least three weeks must have passed since completion of prior radiotherapy. Patients must not have received prior paclitaxel, pemetrexed, or bevacizumab; prior carboplatin is allowed if given as part of adjuvant chemotherapy. Patients must be e" 18 years of age with ECOG PS of 0 or 1. Patients must not have brain metastasis. Patients must not have had major hemoptysis within four weeks prior to registration. Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic CHF, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must have measurable or nonmeasurable disease as defined by RECIST criteria (see Section 6.1.2). Patients with history of HTN must be adequately controlled (PB < 150/100) with appropriate anti-HTN therapy or diet. Patients must not have history of thrombotic events or major bleed within 12 months prior to registration. They must not have had any major surgery, open biopsy or significant traumatic 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 e" 6 months after. Patients with HIV disease must not be taking anti-retroviral therapy. Induction Therapy Step 1 Paclitaxel 200 mg/m2 IV on Day 1 Carboplatin AUC = 6 IV on Day 1 Bevacizumab 15 mg/kg IV on Day 1 Give four 21-day cycles *Randomize patients eligible for Step 2* (Response of stable disease or better per RECIST plus other criteria listed in Section 3.2) Maintenance TherapyStep 2 Arm A: Bevacizumab 15 mg/kg IV on Day 1 Give 21-day cycles until progression or unacceptable toxicity. Arm B: Pemetrexed 500 mg/m2 IV on Day 1 Give 21-day cycles until progression or unacceptable toxicity. Arm C: Pemetrexed 500 mg/m2 IV on Day 1 Bevacizumab 15 mg/kg IV on Day 1 Give 21-day cycles until progression or unacceptable toxicity. MBP Veith EKL-pending MCLNO-pending CALGB 30610 Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide THERAPEUTIC CREDITS: 1.0 CANCER CONTROL CREDITS: 0.5  Patients with histologically or cytologically documented small cell lung cancer. Patients must have limited stage disease that is limited to one hemithorax with regional lymph node metastasis, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes. - Patients must not have disease involvement of the contralateral hilar or supraclavicular lymph nodes, pleural effusions that are visible on plain chest radiographs (whether cytologically positive or not), or cytologically positive pleural or pericardial fluid (whether visible plain chest x-ray or not). Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as e" 2 cm with conventional techniques or as e" 1 cm with spiral CT scan. Patients must not have received any prior radiotherapy or chemotherapy for SCLC. Patients must not have received any prior mediastinal or thoracic radiotherapy. Patients must not have had complete surgical resection of disease. Patients must be e" 18 years of age; ECOG PS 0-2. Patients must not be known to be pregnant or nursing. The following are not exclusion criteria, but physicians should recognize that these conditions may increase the risk to a patient entering the trial: Psychiatric illness that would prevent the patient from giving informed consent. Medical conditions such as uncontrolled infection (including HIV), uncontrolled DM or cardiac disease, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient. Patients with currently active second malignancy other than non-melanoma skin cancers and carcinoma in situ of the cervix. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study. Appropriate methods include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method. Arm A: Cisplatin/Etoposide* x 4 21-day cycles Standard Radiation** (starts Day 1 of Cycle 1 or Cycle 2 of chemo) 45 Gy total dose divided into 1.5 Gy fractions given BID over 3 weeks (total of 30 fractions) Arm B: Cisplatin/Etoposide* x 4 21-day cycles Radiation** (starts Day 1 of Cycle 1 or Cycle 2 of chemo) 70 Gy total dose divided into 2.0 Gy fractions given once daily over 7 weeks (total of 35 frac-tions) Arm C: Cisplatin/Etoposide* x 4 21-day cycles Radiation** (starts Day 1 of Cycle 1 or Cycle 2 of chemo) 61.2 Gy total dose divided into 1.8 Gy fractions given once daily for 16 days and then BID for 9 days (total of 34 fractions over 5 weeks) After the accrual of 30 patients per arm, there will be an interim analysis. Either Arm B or Arm C will be discontinued (based on toxicity) at that time and the study will continue with two arms. * Cisplatin 80 mg/m2 IV on Day 1 of each cycle Etoposide 100 mg/m2 IV on Days 1-3 of each cycle ** All radiation will be given 5 days a week (i.e., M-F).MBPCC CCS  RTOG 0813 Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients Does the patient have a pathologically (histologically or cytologically) proven diagnosis of nonsmall cell lung cancer (NSCLC)? Is the patient AJCC stage T1-2, N0, M0, tumor size d" 5 cm, prior to registration, based upon the minimum diagnostic workup specified in Section 3.1? Was a history/physical examination performed within 4 weeks prior to registration? Was the patient evaluated by an experienced thoracic cancer surgeon within 12 weeks prior to 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 patients 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?Stereotactic body radiation therapy (SBRT)Pending IGRT approval for MBPCC LYMPHOMATITLEELIGIBILITYTREATMENTLOCATIONIRB# 1576: S8947; Central Lymphoma Serum Repository Protocol ANCILLARY 0 rx credits 0 cc creditsFor patients registered to a currently active Southwest Oncology Group-coordinated treatment protocol for previously untreated non-Hodgkin's lymphoma.Central Lymphoma Serum Repository ProtocolMBPCC MULTIPLE MYELOMATITLEELIGIBILITYTREATMENTLOCATIONCALGB 70604: A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer 1 cc credit Histo confirmed adenocarcinoma of prostate or breast or multiple myeloma At least 1 bone mets confirmed by radiographic imaging No prior IV bisphosphonate tx No prior radiopharmaceuticals e" 4 week since completion of radio-therapy No current investigational therapy No brain mets ECOG status of 0-2zoledronic acid (every 12 weeks) versus zoledronic acid (every 4 weeks) MBPCC Veith CCS LSUHSC MOL MCLNO S0777: A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant THERAPEUTIC CREDITS: 1.0  Patients with newly diagnosed multiple myeloma (MM) with measurable disease. Patients with non-secretory MM will be eligible only if the baseline serum Freelite is elevated. Patients must have received no prior chemotherapy for this disease, nor any prior treatment with bortezomib or lenalidomide. They must not have received prior RT to a large area (more than half) of the pelvis. Prior steroid treatment is allowed as long as it was not longer than 2 weeks in duration. Patients must be e" 18 years of age with Zubrod PS of 0-3 (PS 3 allowed only if MM is the central cause of the disability). Patients must be offered participation in the Myeloma Specimen Repository for banking and future research (see Section 15.0 for more information). Sites must submit a local cytogenetics report and FISH analysis report obtained prior to enrollment on S0777. Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity must have these conditions attended to prior to registration. 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Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to the protocol. Patients must not have a history of COPD or chronic respiratory pulmonary disease. Patients must not be Hepatitis B, Hepatitis C, or HIV positive (see Section 5.13 for exception related to treatment-sensitive HIV disease). Patients must not have a history of CVA with persistent neurologic deficits. 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)Arm 1 (LLD): Dexamethasone 40 mg/day PO Days 1, 8, 15, 22 Lenalidomide 25 mg/day PO QD Days 1-21 Aspirin 325 mg/day PO QD continuously Give six 28-day cycles Arm 2 (BLLD): Dexamethasone 20 mg/day PO Days 1, 2, 4, 5, 8, 9, 11, 12 Lenalidomide 25 mg/day PO QD Days 1-14 Bortozomib 1.3 mg/m2 IVP Days 1, 4, 8, 11 Aspirin 325 mg/day QD continuously HSV prophylaxis per institutional standard Give eight 21-day cycles Note: Patients who intend to undergo transplant will undergo PBSC collection during either Arm 1 or Arm 2 treatment, preferably after the second cycle. Maintenance Therapy with LLD: (begins after e" 4 cycles of LLD or e" 6 cycles of BLLD) Dexamethasone 40 mg/day PO Days 1, 8, 15, 22 Lenalidomide 25 mg/day PO QD Days 1-21 Aspirin 325 mg/day PO QD continuously Give 28-day cycles until progression MBPCC CCS Veith MCLNO 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. 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