Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure
Protocol for Assessment of Capecitabine for Advanced Colorectal Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger than 60 Years)
| Study Coordinator(s) | Heinz- Josef Lenz, M.D., Derek Raghavan, M.D.,Ph.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies |
| Closure Date | 2005-02-01 |
Temporary closure
Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
| Study Coordinator(s) | Powel H. Brown, M.D., Ph.D, G. Thomas Budd, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
| Closure Date | 2008-05-13 |
Amendments, Revisions, Memoranda
Amendment #1
Phase II Pilot Study of Rituximab + CHOP in Patients with Newly Diagnosed Waldenstrom's Macroglobulinemia
| Study Coordinator(s) | Gordan Srkalovic, M.D., Ph.D |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
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. |
Revision #9
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 |
Amendment #4
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 #1
Phase II Trial of Surgery with Perioperative INGN 201 (Ad5CMV-p53) Gene Therapy Followed by Chemoradiotherapy for Advanced, Resectable Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx and Larynx
| Study Coordinator(s) | George Yoo, M.D., S.G. Urba, M.D., Harold Kim, M.D., Ehab Hanna, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum
"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 |
Revision #8
A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)
| Action Codes | ER |
| Study Coordinator(s) | Mohamad A. Hussein, M.D., John D. Shaughnessy, Jr., Ph.D., James A. Waldron, M.D.,Ph.D., Jeffrey A. Zonder, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Limited Institutions: BMT Members |
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 |
Memorandum
A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
| Study Coordinator(s) | Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists |
Memorandum
A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin with Molecular Correlates
| Study Coordinator(s) | Primo N. Lara, Jr., M.D., Ralph W. deVere White, M.D., Jeffrey P. Gregg, M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Pathologists, Surgeons |
Amendment #1
Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
| Action Codes | FBR |
| Study Coordinator(s) | Jeffrey A. Zonder, M.D., Bart Barlogie, M.D.,Ph.D., Muneer H. Abidi, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Memorandum
Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
| Action Codes | FBR |
| Study Coordinator(s) | Jeffrey A. Zonder, M.D., Bart Barlogie, M.D.,Ph.D., Muneer H. Abidi, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Amendment #2
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 |
Memorandum
A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
| Action Codes | ER |
| Study Coordinator(s) | Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG |
Revision #2
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 |
Memorandum
A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
| Study Coordinator(s) | Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D. |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
Revision #1
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 |
Amendment #9
A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas(with Possible Late Autologous Stem Cell Transplant) for Patients with Diffuse Aggressive Non-Hodgkin’s Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups (A BMT Study)
| Study Coordinator(s) | Patrick J. Stiff, M.D., Avayporn P. Nademanee, M.D., Richard I. Fisher, M.D., Louis S. Constine, M.D., Raymond R. Tubbs, D.O., James Cook, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, ECOG, NCIC-CTG |
Revision #7
Lung Cancer Specimen Repository Protocol, Ancillary
| Action Codes | NR |
| Study Coordinator(s) | Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG |
Memorandum
Chemoprevention of Recurrent Adenomas and Second Primary Colorectal Carcinoma, A Phase III Pilot Study
| Study Coordinator(s) | David Z.J. Chu, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
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