Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure
Single Agent ZD-1839 in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.
| Study Coordinator(s) | Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D. |
| Participants | Limited: Institutions Listed on the Title Page |
| Closure Date | 2005-02-15 |
Amendments, Revisions, Memoranda
Memorandum
A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
| Study Coordinator(s) | Stephen K. Williamson, M.D. |
| Participants | Members, Surgeons, NCORP |
Memorandum
A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
| Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D. |
| Participants | Members, Surgeons, NCORP |
Amendment #4
Phase II Trial of Chronic Oral ZD1839 (Iressa) in Both Previously-Untreated and Previously-Treated Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
| Study Coordinator(s) | Howard (Jack) West, M.D., Ralph B. Vance, M.D., Wilbur A. Franklin, M.D., Derick H.M. Lau, M.D.,Ph.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum
Phase II Trial of Chronic Oral ZD1839 (Iressa) in Both Previously-Untreated and Previously-Treated Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
| Study Coordinator(s) | Howard (Jack) West, M.D., Ralph B. Vance, M.D., Wilbur A. Franklin, M.D., Derick H.M. Lau, M.D.,Ph.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Amendment #3
A Phase II Study of OSI-774 (NSC #718781) in Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction
| Study Coordinator(s) | Tomislav Dragovich, M.D., Ph.D, James L. Abbruzzese, M.D. |
| Participants | Members, NCORP |
Memorandum
A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
| Study Coordinator(s) | Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, CTSU Institutions in the United States |
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 |
Amendment #2
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
A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
| Study Coordinator(s) | Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
Amendment #3
Single Agent ZD-1839 in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.
| Study Coordinator(s) | Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum
A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
| Study Coordinator(s) | Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG |
Memorandum
Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
| Study Coordinator(s) | Paul J. Hesketh, M.D., Antoinette J. Wozniak, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Revision #2
Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
| 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 as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
| Study Coordinator(s) | Philip Gold, M.D. |
| Participants | Members, NCORP |
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