Priority Lists
Protocol Posting of
Activations
Activation
A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
| Study Coordinator(s) | Heinz- Josef Lenz, M.D. |
| Participants | CTSU |
Activation
Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men
| Study Coordinator(s) | Christine B. Ambrosone, Ph.D., Regina M. Santella, Ph.D., Mary Reid, Ph.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU, CALGB, ECOG, NCCTG, RTOG |
Activation
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 |
Closures
Permanent Closure Effective 10/15/05
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 |
| Closure Date | 2005-10-15 |
Temporary closure effective 10/15/05
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 |
| Closure Date | 2006-01-15 |
Amendments, Revisions, Memoranda
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
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 |
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 | ER |
| 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
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 #2 of 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 |
Revision #1
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 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 |
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 |
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 |
Revision #1
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 |
Memorandum
A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
| Study Coordinator(s) | Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum
A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
| Study Coordinator(s) | Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
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
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 |
Memorandum
A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
| Study Coordinator(s) | Tomasz M. Beer, M.D., Christopher W. Ryan, M.D., Timothy W. Synold, Pharm. D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
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 |
Memorandum
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
| Study Coordinator(s) | Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #2
A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma Comparison of (1) VAD to VAD/ Quinine for Induction with Crossover to VAD/ Quinine for VAD Induction Failures; (2) Alpha-2b Interferon or Alpha-2b Interferon plus Prednisone for Remission Maintenance
| Study Coordinator(s) | Bart Barlogie, M.D.,Ph.D., Thomas M. Grogan, 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