Nevada Cancer Research Foundation

TREATMENT PROTOCOLS

Updated 07/01/2009

Table of Contents

bulletBRAIN
bulletBREAST
bulletGASTROINTESTINAL
bulletGENITOURINARY
bulletGYNECOLOGICAL
bulletHEAD AND NECK
bulletHEMATOLOGICAL
bulletLUNG
bulletLYMPHOMA
bulletMELANOMA
bulletMYELOMA
bulletOTHER

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BRAIN

bullet0320 - A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES
bullet0614 - A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY   
bullet0825 - Phase III Double-Bind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and AdjuvantTemozolomide plus Bevacizumab versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with newly Diagnosed Glioblastoma
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BREAST

ADJUVANT

bullet40101 - Cyclophosphamide and Doxorubicin (CA 4 vs 6 cycles) versus Paclitaxel (4 vs 6 cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A 2x2 Factorial Phase III Randomized Study
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369901 - OBSERVATIONAL COHORT STUDY: CHEMOTHERAPY DECISIONS AND OUTCOMES IN WOMEN AGE 65 OR OLDER WITH OPERABLE, NEWLY DIAGNOSED BREAST CANCER

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S0221- PHASE III TRIAL OF CONTINUOUS SCHEDULE AC + G VS. Q 2 WEEK SCHEDULE AC, FOLLOWED BY PACLITAXEL GIVEN EITHER EVERY 2 WEEKS OR WEEKLY FOR 12 WEEKS AS POST-OPERATIVE ADJUVANT THERAPY IN NODE-POSITIVE OR HIGH -RISK NODE NEGATIVE BREAST CANCER

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B-39/0413 - 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

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Z1031 - A  Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Clinical Stage II and III  Estrogen Receptor Positive Breast Cancer

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pacct-1 - Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

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b-42 - A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting on an Aromatase Inhibitor (AI) or Tamoxifen Followed by and AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer

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B-44 (beth) - A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab  

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E5103 - A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer  

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S0307 - Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

METASTATIC

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S0226 - PHASE III RANDOMIZED TRIAL OF ANASTROZOLE VERSUS ANASTROZOLE AND FULVESTRANT AS FIRST LINE THERAPY FOR POST MENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER Closed to accrual 07/01/2009

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B-37 - A RANDOMIZED CLINICAL TRIAL OF ADJUVANT CHEMOTHERAPY FOR RADICALLY RESECTED LOCO-REGIONAL RELAPSE OF BREST CANCER

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40302 - Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: a Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer

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toc4129g - A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer 

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S0622 - PHASE II STUDIES OF TWO DIFFERENT SCHEDULES OF DASATINIB (NSC-732517) IN BONE METASTASIS PREDOMINANT METASTATIC BREAST CANCER

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GASTROINTESTINAL

ANAL

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COLON

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NCCTG N0147  - A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

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E5202 - Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers  Suspended as of 04/29/2009

COLORECTAL

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80405 - 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

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s0600 - Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) with or without Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX or XELOX TEMPORARILY CLOSED TO ACCRUAL 06/6/2008

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shh4429g - A Randomized, Placebo-Controlled Phase II Study of GDC-0449 (Systemic Hedgehog Antagonist) with Concurrent Chemotherapy and Bevacizumab as First-Line Therapy for Metastatic Colorectal Cancer

ESOPHAGUS

bullet 80302 - A PHASE II TRIAL OF PREOPERATIVE IRINOTECAN, CISPLATIN AND RADIATION IN ESOPHAGEAL CANCER 
bullet0436 - A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated Without Surgery

GASTRIC/GE JUNCTION

 

bulletA6181112 - A Phase IIIB, Randomized, Active Controlled Open-Label Study of Sunitinib (Sutent) 37.5 mg Daily vs Imatinib Mesylate 800 mg Daily in the Treatment of Patient With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease while on 400 mg Daily of Imatinib

RECTAL

bulletR-04 - A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum
bulletE5204 - INTERGROUP RANDOMIZED PHASE III STUDY OF POSTOPERATIVE OXALIPLATIN, 5-FLUOROURACIL AND LEUCOVORIN VS OXALIPLATIN, 5-FLUOROURACIL, LEUCOVORIN AND BEVACIZUMAB FOR PATIENTS WITH STAGE II OR III RECTAL CANCER RECEIVING PRE-OPERATIVE CHEMORADIATION (NASBP R-04 Patients eligible)
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0822 - A PHASE II EVALUATION OF PREOPERATIVE CHEMORADIOTHERAPY UTILIZING INTENSITY MODULATED RADIATION THERAPY (IMRT) IN COMBINATION WITH CAPECITABINE AND OXALIPLATIN FOR PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER

 

PANCREAS

bulletefc6596 - A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) at 90 mg/m2 every 3 weeks Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treatment with a Gemcitabine-Containing Regimen

REGISTRY

bulletCSTI5721BUS227 - Gastrointestinal Stromal Tumors (GIST) Registry Protocol
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GENITOURINARY

BLADDER

bullet0524 - A PHASE I/II TRIAL OF A COMBINATION OF PACLITAXEL AND TRASTUZUMAB WITH DAILY IRRADIATION OR PACLITAXEL ALONE WITH DAILY IRRADIATION FOLLOWING TRANSURETHRAL SURGERY FOR NON-CYSTECTOMY CANDIDATES WITH MUSCLE-INVASIVE BLADDER CANCER Suspended as of 06/05/2009

RENAL

bulletE2805 -  A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma
bulletE4805 - A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma
bulletE2804 - The BeST Trial: A Randomized Phase II Study of VEGF, RAF kinase, and mTOR Combination Targeted Therapy ( CTT ) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma

PROSTATE

bullet0232 - A PHASE III STUDY COMPARING COMBINED EXTERNAL BEAM RADIATION AND TRANSPERINEAL INTERSTITIAL PERMANENT BRACHYTHERAPY WITH BRACHYTHERAPY ALONE FOR SELECTED PATIENTS WITH INTERMEDIATE RISK PROSTATIC CARCINOMA
bullet90202 - 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
bullet0521 - A PHASE III PROTOCOL OF ANDROGEN SUPPRESSION (AS) AND 3DCRT/IMRT VS AS AND 3DCRT/IMRT FOLLOWED BY CHEMOTHERAPY WITH DOCETAXEL AND PREDNISONE FOR LOCALIZED, HIGH-RISK PROSTATE CANCER  
bullet0518 - A Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer
bullet0415 - A PHASE III RANDOMIZED STUDY OF HYPOFRACTIONATED 3D-CRT/IMRT VERSUS CONVENTIONALLY FRACTIONATED 3D-CRT/IMRT IN PATIENTS WITH FAVORABLE-RISK PROSTATE CANCER
bullet90203 - A 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
bulletE3805 - CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease Prostate Cancer
bulletS0421 - PHASE III STUDY OF DOCETAXEL AND ATRASENTAN VERSUS DOCETAXEL AND PLACEBO FOR PATIENTS WITH ADVANCED HORMONE REFRACTORY PROSTATE CANCER
bullet0534 - A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Nodes or Prostate Bed Only Radiotherapy (Sport) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy
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GYNECOLOGICAL

OVARIAN

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CERVICAL

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UTERINE

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ENDOMETRIAL

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HEAD AND NECK

bulletE1302 - Phase III randomized, placebo controlled, trial of docetaxel versus docetaxel plus ZD1839 (Iressa, ZD1839 (Iressa, gefitinib)) in performance status 2 or previously treated patients with recurrent or metastatic head and neck cancer (ARM C CLOSED)
 
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HEMATOLOGICAL

bulletS0106 - A PHASE III STUDY OF THE ADDITION OF GEMTUZUMAB OZOGAMICIN (MYLOTARG®) DURING INDUCTION THERAPY VERSUS STANDARD INDUCTION WITH DAUNOMYCIN AND CYTOSINE ARABINOSIDE FOLLOWED BY CONSOLIDATION AND SUBSEQUENT RANDOMIZATION TO POST-CONSOLIDATION THERAPY WITH GEMTUZUMAB OZOGAMICIN (MYLOTARG®) OR NO ADDITIONAL THERAPY FOR PATIENTS UNDER AGE 56 WITH PREVIOUSLY UNTREATED DE NOVO ACUTE MYELOID LEUKEMIA (AML)
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E2902 - A PHASE III RANDOMIZED STUDY OF FARNESYL TRANSFERASE INHIBITOR R115777 IN ACUTE MYELOID LEUKEMIA (AML) PATIENTS IN SECOND OR SUBSEQUENT REMISSION OR IN REMISSION AFTER PRIMARY INDUCTION FAILURE

 

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LUNG

NON-SMALL CELL

bullet0320 - A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES
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0617 - A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGH-DOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER

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30607 - Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer

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30704 - A Randomized Phase II Study to Assess the Efficacy of Pemetrexed or Sunitinib (NSC #736511, IND #74019) or Pemetrexed plus Sunitinib in the Second-line Treatment of Advanced Non-small Cell Lung Cancer

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A4021016 - Randomized, Open label, Phase III trial of CP‑751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non-Small Cell Lung Cancer

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pshci 08-009 - A MULTICENTER, OPEN-LABEL, RANDOMIZED, PHASE II TRIAL OF DOCETAXEL, CARBOPLATIN AND BEVACIZUMAB AS FIRST-LINE TREATMENT, FOLLOWED BY BEVACIZUMAB PLUS PEMETREXED VERSUS PEMETREXED ALONE AS SECOND-LINE TREATMENT OF STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER  

SMALL CELL

bullet30610 - Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Ciplatin and Etoposide
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LYMPHOMA

HODGKIN'S

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NON-HODGKIN'S

bullet50303 - Phase III Randomized Study of R-CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-cell Lymphomas  
bullet0227 - Phase I/II Study of Pre-Irradiation Chemotherapy with Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma
bulletC05012 - A TWO-ARM, NON-RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF VELCADE (BORTEZOMIB) IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, AND PREDNISONE WITH OR WITHOUT DOXORUBICIN FOLLOWED BY RITUXIMAB MAINTENANCE IN PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA
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MELANOMA

bulletS0438 - A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma Temporary closed to accrual 02/15/2009
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MYELOMA

bulletE1A06 - An Intergroup Phase III Randomized controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy
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E1A05 - Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®)- Lenalidomide (Revlimid®) -Dexamethasone (VRD) versus Bortezomib (Velcade®) -Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen

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OTHER

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