Priority Lists
Protocol Posting of
Activations
Activation
A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients with Relapsing or Resistant Multiple Myeloma
| Study Coordinator(s) | Mohamad A. Hussein, M.D., Gordan Srkalovic, M.D., Ph.D |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Activation
Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma
| Study Coordinator(s) | Ana Aparicio, M.D., Jeffrey S. Weber, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Closures
Permanent Closure Effective 4/1/06
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 |
| Closure Date | 2006-04-01 |
Amendments, Revisions, Memoranda
Revision #9
"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 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 (1 of 2)
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 (2 of 2)
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
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
| Study Coordinator(s) | Halle C.F. Moore, M.D., Silvana Martino, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CALGB, ECOG, IBCSG |
Amendment #2
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 | IP, AC, 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 (1 of 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 (2 of 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 |
Revision #1
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
| Study Coordinator(s) | Daruka Mahadevan, M.D.,Ph.D., Daniel O. Persky, M.D., Catherine Spier, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Amendment #2
A Phase II Study of Depsipeptide (NSC-630176) in Patients with Advanced Transitional Cell Carcinoma of the Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen for Advanced Disease
| Study Coordinator(s) | Daniel P. Petrylak, M.D., Guru Sonpavde, M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists |
Memorandum
A Phase II Study of Depsipeptide (NSC-630176) in Patients with Advanced Transitional Cell Carcinoma of the Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen for Advanced Disease
| Study Coordinator(s) | Daniel P. Petrylak, M.D., Guru Sonpavde, M.D., Paul H. Gumerlock, Ph.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists |
Memorandum
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 |
Memorandum (1 of 2)
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 (2 of 2)
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 (1 of 2)
Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
| Study Coordinator(s) | Philip Gold, M.D. |
| Participants | Members, NCORP |
Memorandum (2 of 2)
Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
| Study Coordinator(s) | Philip Gold, M.D. |
| Participants | Members, NCORP |
Memorandum
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 #1
Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
| Study Coordinator(s) | Jonathan W. Friedberg, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
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 |
Revision #1
Nonmyeloablative Allogeneic Stem Cell Transplantation for Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation (A BMT Study)
| Study Coordinator(s) | Scott E. Smith, M.D., Ph.D, Patrick J. Stiff, M.D. |
| Participants | Limited Institutions: Allogeneic BMT Members |
Memorandum
Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
| Study Coordinator(s) | Margaret von Mehren, M.D., John Goldblum, M.D., George Demetri, M.D., Vivien Bramwell, M.D.,Ph.D. |
| Participants | Intergroup Coalition Against Sarcomas Members, Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum
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 |
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 |
Amendment #3
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
| Study Coordinator(s) | L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D. |
| Participants | Members, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States |
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