Priority Lists
Protocol Posting of
Activations
Activation
A Phase II Study of Iodine-131 Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma
| Action Codes | FBR |
| Study Coordinator(s) | Jonathan W. Friedberg, M.D., Oliver W. Press, M.D.,Ph.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Closures
Permanent Closure
A Phase I and A Randomized Phase II Study of Maximal Angiogenic Blockade in Advanced Renal Carcinoma: Bevacizumab (NSC-704865) with or without MEDI-522 (NSC-719850)
| Action Codes | ER |
| Study Coordinator(s) | Christopher W. Ryan, M.D., Theresa M. Koppie, M.D., Philip C. Mack, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
| Closure Date | 2009-04-01 |
Amendments, Revisions, Memoranda
Memorandum: JMA.17R Advanced Notice of Closure to Accrual
A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
| Study Coordinator(s) | Silvana Martino, D.O. |
Memorandum - Bevacizumab Safety Reports
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)
| Action Codes | ER |
| Study Coordinator(s) | Ralph G Zinner, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #7
A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasma Proliferative Disorders
| Action Codes | ER |
| Study Coordinator(s) | Madhav V. Dhodapkar, M.D., Bart Barlogie, M.D.,Ph.D., John D. Shaughnessy, Jr., Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum - Clodronate Safety Reports
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
| Action Codes | ER |
| 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 |
Revision #1
Long-Term Bone Quality in Women With Breast Cancer (A Companion Study to S0307)
| Action Codes | FBR, ER |
| Study Coordinator(s) | Dawn Hershman, M.D., M.S., Susan M. Ott, M.D., Julie R. Gralow, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Revision #9
A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
| Action Codes | ER |
| Study Coordinator(s) | Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG |
Memorandum - OSI-774 Safety Reports
Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
| Action Codes | ER |
| Study Coordinator(s) | Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Memorandum - Cetuximab Safety Report
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 |
Memorandum - Cetuximab Safety Report
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 |
Memorandum - CCI-779 Safety Report
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 | ER |
| 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 - Bevacizumab Safety Report
A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
| Action Codes | ER |
| Study Coordinator(s) | Charles D. Blanke, M.D., Michael C. Heinrich, M.D., Christopher Corless, M.D., Ph.D |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Bevacizumab Safety Report
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
| Action Codes | ER |
| 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 - Bevacizumab Safety Report
Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
| Action Codes | ER |
| Study Coordinator(s) | James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Revision #2
Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
| Action Codes | ER |
| Study Coordinator(s) | James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum: Change in Drug Ordering Instructions
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
| Action Codes | NR |
| 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 |
Memorandum - Bevacizumab Safety Report
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
| Action Codes | ER |
| 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 1 of 2 - Bevacizumab Safety Report
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 2 of 2 - Cetuximab Safety Report
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Report
Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX
| Action Codes | ER |
| Study Coordinator(s) | Philip Gold, M.D., Anthony Shields, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Bortezomib Safety Report
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
| Action Codes | ER |
| Study Coordinator(s) | Steven Bernstein, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Revision #4
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Anne F. Schott, M.D., Catherine Van Poznak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bortezomib Safety Report
Observational study of asymptomatic Waldenström’s Macroglobulinemia and Phase II study of tandem autologous transplant and maintenance treatment for patients with symptomatic disease
| Action Codes | ER |
| Study Coordinator(s) | Gordan Srkalovic, M.D., Ph.D |
| Participants | Affiliates, NCORP, Limited Institutions: SWOG Approved Autologous BMT Facilities, Medical Oncologists, Members, Pathologists |
Memorandum 1 of 2 - Bevacizumab Safety Report
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
| Action Codes | ER |
| Study Coordinator(s) | Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 2 of 2 - OSI-774 Safety Reports
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
| Action Codes | ER |
| Study Coordinator(s) | Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 1 of 2 - Bevacizumab Safety Report
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
| Action Codes | ER |
| Study Coordinator(s) | Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 2 of 2 - OSI-774 Safety Reports
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
| Action Codes | ER |
| Study Coordinator(s) | Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Reports
A Phase I and A Randomized Phase II Study of Maximal Angiogenic Blockade in Advanced Renal Carcinoma: Bevacizumab (NSC-704865) with or without MEDI-522 (NSC-719850)
| Action Codes | ER |
| Study Coordinator(s) | Christopher W. Ryan, M.D., Theresa M. Koppie, M.D., Philip C. Mack, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - Change in drug ordering instructions
A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM)
| Action Codes | NR |
| Study Coordinator(s) | Sai-Hong Ignatius Ou, M.D., Ph.D, Linda L. Garland, M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates |
Memorandum - OSI-774 Safety Reports
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cancer
| Action Codes | ER |
| Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bortezomib Safety Report
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
| Action Codes | ER |
| Study Coordinator(s) | Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU |
Revision #2
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
| Action Codes | IP, AC, CBR, ER |
| Study Coordinator(s) | Edgar Ben-Josef, M.D., Mark Zalupski, M.D., Andrew M. Lowy, M.D., Christopher Corless, M.D., Ph.D |
| Participants | Members, NCORP, Affiliates, Surgeons, Radiation Oncologists, CTSU |
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