Priority Lists
Protocol Posting of
Activations
Activation
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
| Study Coordinator(s) | Anne F. Schott, M.D., Catherine Van Poznak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Closures
Permanent Closure-Second Registration
L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia
| Study Coordinator(s) | James R. Marshall, Ph.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D., E. David Crawford, M.D., Ian M. Thompson Jr., M.D., Donna L. Berry, R.N.,Ph.D. |
| Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, VA Special Member Institutions |
| Closure Date | 2006-11-01 |
Amendments, Revisions, Memoranda
Memorandum
A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571)(NSC # 716051,IND # 61135), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG
| Study Coordinator(s) | Margaret R. O'Donnell, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Memorandum
Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
| Study Coordinator(s) | Omer Kucuk, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons |
Memorandum
A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevacizumab in Patients with Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)
| Study Coordinator(s) | Ralph G Zinner, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
| Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU |
Memorandum
A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
| Action Codes | ER |
| Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
Memorandum
Pilot Trial of Hyper-CVAD and Methotrexate/ARA C+ Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
| Study Coordinator(s) | Elliot M. Epner, M.D., Ph.D, Thomas P. Miller, M.D., Catherine Spier, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
"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"
| Study Coordinator(s) | G. Thomas Budd, M.D., Halle C.F. Moore, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Memorandum
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
| Study Coordinator(s) | Julie R. Gralow, M.D., Robert B. Livingston, M.D., Daniel F. Hayes, M.D., Dawn Hershman, M.D., M.S., Alison T. Stopeck, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU |
Memorandum
Evaluation of CHOP Plus Involved Field Radiotherapy followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE and non-bulky Stages II and IIE, CD20 Positive, High-risk Localized, Aggressive Histologies of Non-Hodgkin's Lymphoma, Phase II
| Study Coordinator(s) | Thomas P. Miller, M.D., Louis S. Constine, M.D., B. Dino Stea, M.D.,Ph.D., Catherine Spier, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum
Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
| Action Codes | ER |
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Revision #4
A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
| Study Coordinator(s) | Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D. |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
Memorandum
A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer
| Study Coordinator(s) | Christopher W. Ryan, M.D., Tomasz M. Beer, M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists |
Memorandum
Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
| Study Coordinator(s) | Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons |
Memorandum
Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
| Study Coordinator(s) | Philip Gold, M.D. |
| Participants | Members, NCORP |
Memorandum
Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients with Recurrent or Metastatic Head and Neck Cancer
| Study Coordinator(s) | Stephen K. Williamson, M.D., Chao Hui Huang, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Memorandum
A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Yuhchyau Chen, M.D., Ph.D, Kishan J. Pandya, M.D., Karen Kelly, M.D., Derick H.M. Lau, M.D.,Ph.D., Laurie E. Gaspar, M.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists |
Revision #6
Phase II Studies of Two Different Schedules and Two Different Doses of the Farnesyl Transferase Inhibitor R115777 (Tipifarnib, Zarnestra®, NSC-702818)for Previously Untreated Acute Myeloid Leukemia (AML) in Patients of Age 70 or Older.
| Action Codes | NR |
| Study Coordinator(s) | Harry P. Erba, M.D.,Ph.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Memorandum
Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
| Study Coordinator(s) | Jonathan W. Friedberg, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
| Study Coordinator(s) | Jonathan W. Friedberg, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients with Relapsing or Resistant Multiple Myeloma
| Action Codes | ER |
| Study Coordinator(s) | Mohamad A. Hussein, M.D., Gordan Srkalovic, M.D., Ph.D |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer
| Study Coordinator(s) | Barbara J. Gitlitz, M.D., Bonnie S. Glisson, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum
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
| Action Codes | FBR |
| Study Coordinator(s) | Kim A. Margolin, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D., Lawrence E. Flaherty, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, ECOG |
Memorandum
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
| Study Coordinator(s) | Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States |
Memorandum
Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
| Study Coordinator(s) | Margaret von Mehren, M.D., John Goldblum, M.D., George Demetri, M.D., Vivien Bramwell, M.D.,Ph.D. |
| Participants | Intergroup Coalition Against Sarcomas Members, Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Revision #3
Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
| Study Coordinator(s) | Margaret von Mehren, M.D., John Goldblum, M.D., George Demetri, M.D., Vivien Bramwell, M.D.,Ph.D. |
| Participants | Intergroup Coalition Against Sarcomas Members, Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum
Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma
| Action Codes | ER |
| Study Coordinator(s) | Ana Aparicio, M.D., Jeffrey S. Weber, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma
| Study Coordinator(s) | Anthony El-Khoueiry, M.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP |
Memorandum
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
| Study Coordinator(s) | Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
| Study Coordinator(s) | Mark H. Kirschbaum, M.D., Jasmine M. Zain, M.D., Lisa M. Rimsza, M.D., Raymond R. Tubbs, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Amendment #1
Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989; IND-75,093) and Everolimus (RAD001; NSC-733504; IND-75,093) in Patients with Advanced Solid Tumors
| Study Coordinator(s) | Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D., Patricia LoRusso, D.O., Jennifer Carew, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Revision #5
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
| Study Coordinator(s) | Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma
| Study Coordinator(s) | Steven Bernstein, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
A 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 (A BMT Study)
| Study Coordinator(s) | Patrick J. Stiff, M.D., Avayporn P. Nademanee, M.D., Richard I. Fisher, M.D., Louis S. Constine, M.D., Raymond R. Tubbs, D.O., James Cook, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, ECOG, NCIC-CTG |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required