Priority Lists
Protocol Posting of
Activations
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 |
Activation
Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients with Advanced or Metastatic Gastric Cancer
| Study Coordinator(s) | Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Closures
Permanent Closure
A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) versus Docetaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients with a Rising PSA after Hormonal Therapy for Prostate Cancer
| Study Coordinator(s) | Nirmala Bhoopalam, M.D., Gregory P. Swanson, M.D. |
| Participants | CTSU |
| Closure Date | 2004-12-28 |
Amendments, Revisions, Memoranda
Revision #4
A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC-616348) Plus Fluorouracil/Leucovorin (5FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection For Patients With Stage III Colon Cancer.
| Study Coordinator(s) | Alexander Hantel, M.D. |
| Participants | Pathologists, NCORP, Members |
Revision #7
Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler - Coller B2) Adenocarcinoma of the Colon.
| Study Coordinator(s) | R.L. Martino, M.D. |
| Participants | Members, Surgeons, Pathologists, NCORP |
Memorandum
Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC #706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients with Untreated Acute Promyelocytic Leukemia
| Action Codes | ER |
| Study Coordinator(s) | Steven E. Coutre, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D. |
| Participants | Pathologists, NCORP, Members |
Revision #4
A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with "No Evidence of Disease" after Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Kim A. Margolin, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists |
Revision #3
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 |
Amendment #3
"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
| Study Coordinator(s) | George Demetri, M.D., Christopher Fletcher, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG |
Memorandum
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
| Action Codes | ER, NR |
| Study Coordinator(s) | Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Revision #2
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
| Action Codes | ER, NR |
| Study Coordinator(s) | Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Memorandum
A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg™) and Standard Dose Ara-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
| Study Coordinator(s) | John E. Godwin, M.D., Margaret R. O'Donnell, M.D., David R. Head, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
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 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 #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 |
Revision #1
Barriers to Accrual to Clinical Trials in Older (>= 65 Years) Cancer Patients
| Study Coordinator(s) | Julie R. Gralow, M.D., Antoinette J. Wozniak, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Amendment #1
Phase II Trial of Imatinib Mesylate (Gleevec) (NSC-716051) In Combination With Capecitabine (Xeloda) (NSC-712807) In Metastatic Breast Cancer
| Study Coordinator(s) | Helen K. Chew, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #2
Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) with Advanced Stage Diffuse Large B-cell NHL of Low and Low-Intermediate IPI Risk
| Study Coordinator(s) | Steven Bernstein, M.D., Richard I. Fisher, M.D., Thomas M. Grogan, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Revision #1
A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer
| Study Coordinator(s) | Christopher W. Ryan, M.D., Tomasz M. Beer, M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, 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