CancerPACT Cancer Patients Alliance for Clinical Trials

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1 TM CancerPACT Cancer Patients Alliance for Clinical Trials Listing of Ongoing Cancer Clinical Trials in the Sacramento Area Winter 2008 I. Solid Tumors 1. Breast p.1 2. Central Nervous System p.2 3. Gastrointestinal p.3 4. Gynecologic p.4 5. Head & Neck p.4 6. Lung p.5 7. Melanoma p.6 8. Mesothelioma p.6 9. Prostate p Sarcoma p Urologic p.7 II. Hematologic Cancers 1. Leukemia p.7 2. Lymphoma p.8 3. Myeloma p.8 III. Other p.8 I. Solid Tumors 1. Breast Cancer 1. Phase III Randomized Study of 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 2. Randomized Phase III Study of Conventional Whole Breast IrradiationVersus Partial Breast Irradiation For Women With Stage 0, I, or II Breast Cancer

2 2 3. Phase III Trial of Continuous Schedule AC + G vs. Q2 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 (SCC, UCD) 4. Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer 5. Phase III Trial Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer 6. Phase III, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated Metastatic Breast Cancer (MGH, UCD) 7. Prospective, Randomized, Double-Blind, Stratified, Placebo-Controlled, Multi-Center, 3-Arm Trial of the Continued Efficacy and Safety of Zometa (Every 4 Weeks vs. Every 12 Weeks vs. Placebo) in Patients with Documented Bone Metastases From Breast Cancer 8. Randomized Phase III Trial of Neoadjuvant Chemotherapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pcr) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pcr With Each of the Regimens (SCC) 9. Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer 10. Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer (SCC, UCD) 11. Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemustane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer (MGH) 12. Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer (SCC) 13. Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node Negative Breast Cancer (SCC) 14. The TAILORx Trial: Program for the Assessment of Clinical Cancer Tests (PAACT-1): Trial Assigning Individualized Options for Treatment Endocrine Responsive Breast Cancer (SCC, UCD) 15. Phase I/II Trial of Abraxane TM (ABI-007) and ALIMTA (Pemetrexed) in Advanced Solid Tumors with Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer 16. Serum Glycan Analysis in Breast Cancer 17. Open-Label, Multicenter Study of Lapatinib in Combination with Chemotherapy in Patients with ErbB2 Overexpressing Breast Cancer after Trastuzumab Failure in the Neoadjuvant or Adjuvant Setting (MGH) 2. Central Nervous System Tumors 1. Phase III Trial comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolmide in Patients with Newly Diagnosed Glioblastoma 2. Phase III Randomized, Double Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hcrf) to Placebo for Control of Symptoms Associated with Peritumoral Brain Edema in Patients with Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone

3 3 3. 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 4. Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro- Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients 5. Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low Grade Gliomas 3. Gastrointestinal Cancers A. Colorectal Cancer 1. 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 2. 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 3. Phase III Multi-Center, Randomized Clinical Trial to Evaluate the Safety and Efficacy of Cofactor and 5-FU plus Bevacizumab vs. Leucovorin and 5-FU plus Bevacizumab as Initial Treatment for Metastatic Colorectal Cancer (MGH) 4. Phase III Intergroup Randomized 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 Preoperative Chemoradiation 5. Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5- Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum B. Esophageal Cancer 1. Phase II Trial Oxaliplatin Plus Protracted Infusion 5-Flourouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates. C. Liver Cancer 1. Phase II Trial of Dasatinib (BMS ) in Advanced Hepatocellular Carcinoma

4 4 4. Gynecologic Cancers A. Cervical Cancer 1. Phase III Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIB, IIIB, and IVA Cervical Carcinoma Limited to the Pelvis 2. Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with Either Endometrial or Cervical Carcinoma 3. Phase II Study of Bevacizumab in Combination with Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients with Locally Advanced Cervical Carcinoma B. Ovarian/Peritoneal Cancer 1. Phase III Randomized Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax, Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy 2. Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer (SCC, UCD) 3. Randomized, Parallel Group, Open-Label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin (Doxil /Caelyx ) in Taxane/Platinum Refractory/Resistant Patients with Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer 4. Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer 5. A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva C. Uterine Cancer - none 5. Head & Neck Cancer 1. Phase III Randomized Trial of Concurrent Accelerated Radiation and Cisplatin vs. Concurrent Accelerated Radiation, Cisplatin and Cetuximab (C225) [Followed by Surgery for Selected Patients] For Stage III and IV Head and Neck Carcinomas 2. Phase III, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# ; IND #100, 192) for the Reduction of Oral Mucositis in Patients with Locally Advanced Head and Neck Cancer Receiving Radiation Therapy with Concurrent Chemotherapy (Followed by Surgery for Selected Patients) 3. Establishment of a Head and Neck Cancer Tissue/Specimen Bank 4. Phase II Evaluation of E7389 (NSC ) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

5 5 5. Phase I Study of Paclitaxel Poliglumex and Radiation for Squamous Cancer of the Head and Neck 6. Lung Cancer 1. Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer 2. 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 3. Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I, Non-Small Cell Lung Cancer (MGH) 4. Phase III Randomized, Double Blind, Placebo-Controlled Trial Comparing Bevacizumab Therapy with or without Erlotinib after Completion of Chemotherapy with Bevacizumab for the First Line Treatment of Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (MGH) 5. Phase III National Web-Based Randomized Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin and Thoracic Radiotherapy in Patients with Inoperable Stage III Non-Small Cell Lung Cancer (MGH) 6. Phase II Study of Weekly Intravenous Hycamtin and Carboplatin as First-Line Treatment of Chemonaive Subjects with Extensive Small Cell Lung Cancer (MGH) 7. Phase II Randomized Trial of Sequential Versus Concurrent Docetaxel and PS-341 in Previously Treated Non-Small Cell Lung Cancer 8. Phase II Study of the Halichondrin B Analog E7389 in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with a Taxane 9. Phase II Study of Vorinostat or Placebo in Combination with Carboplatin and Paclitaxel for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NCI #7863) 10. Phase II Study of AZD 2171 in Patients with Recurrent Small Cell Lung Cancer (NCI #7097) 11. Phase II Trial of Pemetrexed in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) 12. Phase 2 Study of XL647 in Subjects with Non-Small Cell Lung Cancer Who have Progressed after Responding to Treatment with Either Gefitinib or Erlotinib XL Phase I/II Study of Docetaxel and OSI-774 in Solid Tumor Patients with an Emphasis on NSCLC Using Molecular Correlates As Potential Markers of Response 14. Phase I/II Trial of Abraxane TM (ABI-007) and ALIMTA (Pemetrexed) in Advanced Solid Tumors with Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer 15. Phase I/II Dose Intensification Study of Three Dimensional Conformal Radiation Therapy and Concurrent Chemotherapy for Patients with Inoperable Non-Small Cell Lung Cancer 16. Phase I/II Study of Two Different Schedules of Pemetrexed (ALIMTA) and Erlotinib (TARCEVA) in Advanced Solid Tumors, with Emphasis on Non-Small Cell Lung Cancer 17. Phase I/II Study of Erlotinib (TARCEVA) and Cetuximab (ERBITUX) in Advanced Solid Tumors with an Emphasis on Non-Small Cell Lung Cancer 18. Phase I Pilot Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer

6 6 19. Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC ) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer 20. EGFR Pathway Mutations in Lung Cancer Patient Tumors and Blood 21. Ancillary, Lung Cancer Specimen Repository Protocol 7. Melanoma 1. Phase II Study Evaluating the Efficacy of VEGF Trap in Patients with Recurrent Inoperable Stage III or Stage IV Melanoma (NCI #7522) 8. Mesothelioma 1. Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC ) in Malignant Pleural Mesothelioma 9. Prostate Cancer 1. Phase III, Randomized, Open Label Study Evaluating DN-101 in Combination with Docetaxel in Androgen Independent Prostate Cancer (contact: Kirsten Babski or Lori Ried SCC, Natasha Perkins UCD) 2. Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable Risk Prostate Cancer (contact: Frances Lara, UCD) 3. Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMART vs. Androgen Suppression (AS) and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer (contact: Frances Lara, UCD) 4. Phase III Randomized Study of High Dose 3D-CRT Versus Standard Dose 3D-CRT in Patients Treated for Localized Prostate Cancer (contact: Frances Lara, UCD) 5. Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III Brian Kuest (contact: Frances Lara, UCD) 6. Phase III Trial of Adjuvant Androgen Deprivation Versus Mitoxantrone + Prednisone + Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy. (contact: Brian Kuest, UCD) 7. Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (Provenge, APC8015) in Asymptomatic Subjects with Gleason Sum < 7, Metastatic, Androgen Independent Prostatic Adenocarcinomas (contact: Kirsten Babski or Lori Ried, SCC) 8. Phase II Trial of Daily, Oral Gleevec (Imatinib Mesylate,STI571) in Combination with Every-Three-Week Intravenous Docetaxel in Patients with Metastatic Hormone- Refractory Prostate Cancer (contact: Cammy Rieger, UCD)

7 7 10. Sarcoma 1. Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS) 2. Groupwide Biology and Banking Study for Ewing Sarcoma 11. Urologic Cancer (other) A. Bladder / Urethral Cancer 1. Phase II Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Recurrent or Metastatic Transitional Cell Carcinoma of the Urothelium 2. Phase II Study of VEGF Trap in Patients with Recurrent or Metastatic Transitional Carcinoma of the Urothelium 3. Phase I/II Study of E7389 Halichondrin B Analog in Metastatic Urothelial Tract Cancer and Renal Insufficiency B. Kidney Cancer 1. Phase III Randomized, Double-Blind Trial of Adjuvant Sunitinib Versus Sorafenib Versus Placebo in Patients with Resected Renal Cell Carcinoma CTSU E Phase II Trial of ZD1839 (IRESSA) and Pegylated Interferon Alfa 2B (PEG-Intron) in Unresectable or Metastatic Renal Cell Carcinoma II. Hematologic Cancers 1. Leukemia 1. Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia with Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy 2. Phase II Study of Lenalidomide (Revlimid ) (NSC ) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Therapy 3. Phase II Study of VEGF Trap (NSC ) in Patients with MDS (NCI #7518) 4. Reduced Intensity Stem Cell Transplantation (RIST) for Patients with Hematological Malignancies Conditioned with Fludarabine and Busulfan 5. High Risk B-Precursor Acute Lymphoblastic Leukemia 6. Cytogenetic Studies in Leukemia Patients 7. Leukemia Centralized Reference Laboratories and Tissue Repositories

8 8 2. Lymphoma 1. Phase III Trial of CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin s Lymphomas 2. Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (with Possible Late Autologous Stem Cell Transplant) for Patients with Diffuse Aggressive Non-Hodgkin s Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups 3. Randomized Phase III Study for The Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma 4. Phase II Tandem Autologous Stem Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study) 5. Central Lymphoma Repository Tissue Procurement Protocol for Relapse or Recurrent Disease, Ancillary 6. Reduced Intensity Stem Cell Transplantation (RIST) for Patients with Hematological Malignancies Conditioned with Fludarabine and Busulfan UCDCC# Phase I Study of GX (NSC# ) and Bortezomib in Aggressive Relapsed/Rucurrent Non-Hodgkin's Lymphoma (NCI #7943) 8. Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma (NCI #6963) 3. Myeloma 1. Phase IV Open Label Trial Using Velcade for the Re-Treatment of the Multiple Myeloma Patients Following an Initial Response to Velcade (MGH) 2. Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m2) and Autologous Peripheral Blood Stem Cell Supported Transplantation for Patients with AL Amyloidosis or High Risk (Greater Than or Equal to Age 70 or Poor Renal Function) Patients with Multiple Myeloma (A BMT Study) 3. Myeloma Specimen Repository Protocol, Ancillary 4. Reduced Intensity Stem Cell Transplantation (RIST) for Patients with Hematological Malignancies Conditioned with Fludarabine and Busulfan UCDCC#196 III. Other 1. Phase II Study of Bay for Patient with Imatinib and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor (NCI #7028) 2. Phase I and Pharmacokinetic Study of Oral 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in the Treatment of Advanced Solid Tumors 3. Phase I Trial of PXD101 in Combination with 13-cis-Retinoic Acid in Advanced Solid Tumor Malignancies

9 9 4. Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients with Malignant Solid Tumors 5. Phase I Study of Halichondrin B Analog (E7389) in Combination with Cisplatin in Advanced Solid Tumors 6. Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC ; IND- 75,093) and Everolimus (RAD001; NSC ; IND-75,093) in Patients with Advanced Solid Tumors 7. Phase I Study of Two Different Schedules of Lapatinib (GW572016) in Combination with Vinorelbine in Advanced Solid Tumors 8. Phase I Study of Bortezomib in Patients With Advanced Malignancies and Renal Insufficiency 9. Phase I Study of PXD101 and Isotretinoin in Patients With Metastatic or Unresectable Solid Tumors 10. Phase I Study of 5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Patients With Advanced Solid Tumors 11. Phase I Study of Lapatinib Ditosylate and Vinorelbine Ditartrate in Patients With Advanced Solid Tumors 12. Phase I Study of Bortezomib and Topotecan Hydrochloride in Patients With Advanced Solid Tumors, Including Small Cell Lung Cancer 13. Phase I Study of 3-AP in Patients With Advanced or Metastatic Solid Tumors 14. Phase I Study of Fenretinide in Patients With Metastatic or Unresectable Malignant Solid Tumors 15. Phase I Study of E7389 and Cisplatin in Patients With Advanced Solid Tumors 16. Phase I Study of ABT-888, Carboplatin, and Paclitaxel in Patients With Advanced Solid Malignancies 17. Phase I Pharmacokinetic and Pharmacodynamic Study of Temsirolimus (CCI-779) in Patients with Advanced Malignancies and Normal and Impaired Liver Function: An NCI Organ Dysfunction Working Group Study 18. Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC ; IND- 75,093) and Everolimus (RAD001; NSC ; IND-75,093) in Patients with Advanced Solid Tumors 19. Simultaneous Trial: Linking Palliation to Clinical Trial 20. Multi-Center Human Alert Trial to Prevent DVT and PE 21. Tumor Metrics in Cancer Therapeutics ( UCD) 22. The Predictive Value of Coagulation Markers in Identifying Patients with Solid Tumors at High Risk for Venous Thromboembolism During Chemotherapy