Priority Lists
Protocol Posting of
Activations
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Lori J. Pierce, M.D. |
| Participants | CTSU |
Activation
A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma
| Study Coordinator(s) | Gordan Srkalovic, M.D., Ph.D, Mohamad A. Hussein, M.D., Joshua Epstein, DSC, John D. Shaughnessy, Jr., Ph.D. |
| Participants | Members, NCORP, Medical Oncologists |
Closures
Permanent Closure effective 8/6/05
Trial of Chemotherapy Intensification Through Interval Compression in Ewing Sarcoma and Related Tumors, Phase III
| Study Coordinator(s) | Karen H. Albritton, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons, Radiation Oncologists |
| Closure Date | 2005-08-06 |
Permanent Closure Effective 8/19/05
Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC).
| Study Coordinator(s) | Angela M. Davies, M.D., Raja Mudad, M.D., FACP, Peter F. Roberts, M.D., Derick H.M. Lau, M.D.,Ph.D., Deborah S. Ward, NP |
| Participants | Limited: Institutions Listed on the Title Page |
| Closure Date | 2005-08-19 |
Amendments, Revisions, Memoranda
Amendment #1
A Trial of Tandem Autologous Stem Cell Transplants +/- Post Second Autologous Transplant Maintenance Therapy Versus Single Autologous Stem Cell Transplant Followed by Matched Sibling Non-Myeloablative Allogeneic Stem Cell Transplant for Patients with Multiple Myeloma
| Study Coordinator(s) | George Somlo, M.D. |
| Participants | Limited Institutions: BMT Members |
Memorandum & Corrected Memorandum
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 #6
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 |
Amendment #4
"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
"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 |
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 |
Revision #1
Adjuvant Chemo-Radiotherapy with Combination of Cisplatin (NSC-119875)and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
| Study Coordinator(s) | Prakash C. Neupane, M.D., Harold Kim, M.D., Stephen K. Williamson, M.D., George Yoo, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists |
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 |
Memorandum
A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients with Clinical T3-T4 Rectal Cancer
| Study Coordinator(s) | Charles R. Thomas Jr., M.D., Heinz- Josef Lenz, M.D., Robert P. Whitehead, M.D., James L. Abbruzzese, M.D., Stephen R. Smalley, M.D., Morton S. Kahlenberg, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists |
Revision #2
Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC).
| Study Coordinator(s) | Angela M. Davies, M.D., Raja Mudad, M.D., FACP, Peter F. Roberts, M.D., Derick H.M. Lau, M.D.,Ph.D., Deborah S. Ward, NP |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum
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 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 |
Amendment #2
Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
| Study Coordinator(s) | Paul J. Hesketh, M.D., Antoinette J. Wozniak, 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
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 #3
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 |
Amendment #4
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
Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
| Action Codes | ER |
| Study Coordinator(s) | Lawrence P. Leichman, M.D., Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D., Thomas J. Watson, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons |
Revision #2
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 |
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
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 |
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