Priority Lists
Protocol Posting of
Activations
Activation
A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated with Systemic Therapy plus Either Radiotherapy to all Sites of Gross Residual Disease or No Radiotherapy
| Study Coordinator(s) | Laurie E. Gaspar, M.D., Paul J. Hesketh, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists |
Closures
Permanent Closure Effective 5/29/09
Phase III Intergroup Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma
| Study Coordinator(s) | Tomislav Dragovich, M.D., Ph.D |
| Participants | CTSU |
| Closure Date | 2009-05-29 |
Permanent Closure, effective July 1, 2009
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
| Action Codes | ER |
| Study Coordinator(s) | Rita S. Mehta, M.D., Kathy Albain, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU |
| Closure Date | 2009-07-01 |
Amendments, Revisions, Memoranda
Memorandum - Updates #0102-053 through #0102-062
A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-Myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma
| Action Codes | NR |
| Study Coordinator(s) | George Somlo, M.D. |
| Participants | Limited Institutions: BMT Members |
Memorandum: Drug Supply Update
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. |
Revision #13
Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
| Study Coordinator(s) | Silvana Martino, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons |
Memorandum: Temporary Clodronate Shortage
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
| Action Codes | NR |
| 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 #2
A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
| Action Codes | ER |
| Study Coordinator(s) | Edward M. Messing, M.D., Deepak M. Sahasrabudhe, M.D., Theresa M. Koppie, M.D., David P. Wood Jr., M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Pathologists |
Revision #2
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 | IP, ER |
| Study Coordinator(s) | Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
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
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
| Action Codes | NR |
| Study Coordinator(s) | David I. Quinn, M.D., Ph.D, Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Mark G. Garzotto, M.D., Carol M. Moinpour, Ph.D., Philip C. Mack, Ph.D., Karen M. Baranowski, N.P. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, CTSU Institutions in the United States |
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 - R115777 Safety Report
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 | ER |
| 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 - R115777 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 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 - 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 |
Revision #4
A Randomized Trial of Maintenance versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III
| Action Codes | ER |
| Study Coordinator(s) | Steven E. Coutre, M.D., Diane L. Persons, M.D., Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, 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 - 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 - 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 | IP, AC, CBR, 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 |
Revision #4
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 | IP, AC, CBR, 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
| Action Codes | IP, AC, CBR, 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 |
Revision #4
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 | IP, AC, CBR, 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 |
Revision #2
A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
| Action Codes | ER |
| Study Coordinator(s) | Sucha Nand, M.D., John E. Godwin, M.D., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Members, Medical Oncologists, Pathologists |
Revision #2
A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics
| Action Codes | IP, AC, CBR, ER |
| Study Coordinator(s) | Primo N. Lara, Jr., M.D., Paul J. Hesketh, M.D., Philip C. Mack, Ph.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Affiliates |
Revision #1
A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-operative Therapy of Rectal Cancer
| Action Codes | AC, ER |
| Study Coordinator(s) | Cynthia G. Leichman, M.D., Stephen R. Smalley, M.D., Kevin G. Billingsley, M.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons |
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 |
Reactivation Revision
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 | IP, AC, CBR, ER |
| Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #5
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 | IP, AC, CBR, ER |
| Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
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