Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure effective January 1, 2009
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 |
| Closure Date | 2009-01-01 |
Temporary Closure, effective January 15, 2009
Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
| Action Codes | ER |
| Study Coordinator(s) | Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
| Closure Date | 2009-05-01 |
Amendments, Revisions, Memoranda
Revision #4
S0000D, "A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT, Phase III Ancillary to S0000-SELECT
| Action Codes | NR |
| Study Coordinator(s) | M. Peter Lance, M.D., David S. Alberts, M.D., Achyut Battacharyya, M.D., Sylvan Green, M.D., Maria Elena Martinez, Ph.D. |
| Participants | Participating Study Centers listed in Appendix Section 19.1 |
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 |
Memorandum - Cetuximab Safety Reports
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 Reports
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 - BAY 9006 Safety Report
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 |
Memoranda 1 of 2 - BAY 43-9006 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 |
Memoranda 2 of 2 - CC1-779 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 |
Revision #3
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 Reports
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 - BAY 9006 Safety Report
Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
| Action Codes | ER |
| 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 - AZD2171 Safety Reports
A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
| Action Codes | ER |
| Study Coordinator(s) | Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum - BAY 43-9006 Safety Report
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 - Bevacizumab Safety Reports
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 Reports
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 - Bevacizumab Safety Reports
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 - Bevacizumab Safety Reports
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 - Cetuximab Safety Reports
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 Reports
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 - Leucovorin Shortage
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 - E7389 Safety Reports
Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
| Action Codes | ER |
| Study Coordinator(s) | Susanne M. Arnold, M.D. |
| Participants | Members, NCORP, Affiliates |
Memorandum - Bevacizumab 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 - Bevacizumab 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
| 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 - IMC-A12 Safety Report
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 |
Revision #4
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 |
Amendment #4
L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia
| Action Codes | IP, AC, RC, FBR |
| 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 |
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