Priority Lists
Protocol Posting of
Activations
Closures
Temporary Closure
MVAC in Organ-Confined Bladder Cancer Based on p53 Status
| Study Coordinator(s) | Seth P. Lerner, M.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists |
| Closure Date | 2006-03-28 |
Permanent closure
A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With Her-2 Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy – Phase III
| Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph, Francisco J. Esteva, M.D., Ph.D |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
| Closure Date | 2006-02-01 |
Permanent Closure Effective 2/15/06
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 |
| Closure Date | 2006-02-21 |
Amendments, Revisions, Memoranda
Revision #4
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 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
Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
| Study Coordinator(s) | Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
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 |
Revision #4
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
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) In Patients with Malignant Pleural Mesothelioma
| Study Coordinator(s) | Linda L. Garland, M.D., Michael Lobell, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Amendment #3
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
A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
| Study Coordinator(s) | Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG |
Memorandum
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
| Study Coordinator(s) | Karen H. Albritton, M.D., R. Lor Randall, M.D., Cheryl Coffin, M.D., Nancy Ratner, Ph.D., Scott Schuetze, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU |
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 |
Memorandum
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 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 |
Revision #1
Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
| Study Coordinator(s) | Warren Chow, M.D., John Goldblum, M.D., Diane L. Persons, M.D., Ernest C. Borden, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D. |
| Participants | Intergroup Coalition Against Sarcomas Members in the United States, Members, NCORP, Surgeons, Pathologists, CTSU Institutions in the United States |
Amendment #1
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 |
Amendment #1
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
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 |
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