Priority Lists
Protocol Posting of
Activations
Activation
A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and BAY 43-9006 versus Carboplatin, Paclitaxel and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma
| Study Coordinator(s) | Lawrence E. Flaherty, M.D. |
| Participants | CTSU |
Re-Activation
A Randomized Phase III Trial of Exemestane Versus Anastrozole With or Without Celecoxib in Postmenopausal Women With Receptor Positive Primary Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | G. Thomas Budd, M.D. |
| Participants | CTSU |
Re-Activation
A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
| Study Coordinator(s) | Geoffrey R. Barger, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Activation
Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma
| Study Coordinator(s) | Ernest C. Borden, M.D., Rashmi Chugh, M.D., George Demetri, M.D., Margaret von Mehren, M.D., Vivien Bramwell, M.D.,Ph.D., Karen H. Albritton, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Intergroup Coalition Against Sarcomas Members, CTSU |
Closures
Permanent Closure
A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients with Advanced Renal Cell Cancer
| Study Coordinator(s) | Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists |
| Closure Date | 2005-08-15 |
Permanent Closure Effective 8/1/05
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 |
| Closure Date | 2005-08-01 |
Amendments, Revisions, Memoranda
Amendment #6
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
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
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 |
Revision #9
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
A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
| Study Coordinator(s) | Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
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 #6
A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
| Study Coordinator(s) | Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D., Zelanna Goldberg, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists |
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 |
Revision #4
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 |
Revision #4
A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer.
| Study Coordinator(s) | Primo N. Lara, Jr., M.D., Angela M. Davies, M.D., Paul H. Gumerlock, Ph.D., Wilbur A. Franklin, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Revision #4
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 Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
| Study Coordinator(s) | Robert P. Whitehead, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Revision #3
"A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)."
| Study Coordinator(s) | Angela M. Davies, M.D., Primo N. Lara, Jr., 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 #2
Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients with Recurrent or Metastatic Head and Neck Cancer
| Study Coordinator(s) | Stephen K. Williamson, M.D., Chao Hui Huang, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Revision #3
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 |
Revision #4
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
Phase II Trial of Combination Thalidomide plus Temozolomide in Patients with Metastatic Melanoma
| Study Coordinator(s) | Joseph I. Clark, M.D., Laura F. Hutchins, M.D., Jeffrey A. Sosman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
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