Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure Effective 8/30/07
A Phase III Comparison of Prophylactic Cranial Irradiation versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer
Study Coordinator(s) | Laurie E. Gaspar, M.D. |
Participants | CTSU |
Closure Date | 2007-08-30 |
Temporary Closure effective 9/5/2007
A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia with Multilineage Dysplasia
Study Coordinator(s) | Harry P. Erba, M.D.,Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Permanent Closure Effective 10/1/07
A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Study Coordinator(s) | Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D. |
Participants | Members, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB |
Closure Date | 2007-10-01 |
Permanent Closure Effective 9/15/07
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Closure Date | 2007-09-15 |
Amendments, Revisions, Memoranda
Revision #8
Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
Study Coordinator(s) | Lawrence E. Flaherty, M.D. |
Participants | CTSU |
Revision #1
A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevacizumab in Patients with Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)
Study Coordinator(s) | Ralph G Zinner, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #6
A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s) | Geoffrey R. Barger, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Revision #10
A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D., David G. Maloney, M.D.,Ph.D., Rita M. Braziel, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU |
Revision #10
"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 |
Amendment #1
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
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 |
Amendment #1
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 |
Memorandum (Intellectual Property) & Memorandum (Clodronate Safety Reports)
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Study Coordinator(s) | Julie R. Gralow, M.D., Robert B. Livingston, M.D., Daniel F. Hayes, M.D., Dawn Hershman, M.D., M.S., Alison T. Stopeck, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU |
Memorandum
A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
Study Coordinator(s) | Edward M. Messing, M.D., Deepak M. Sahasrabudhe, M.D., Theresa M. Koppie, M.D., David P. Wood Jr., M.D., Philip C. Mack, Ph.D. |
Participants | Members, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Pathologists |
Memorandum
Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Action Codes | ER |
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 #5
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 |
Memorandum
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 |
Memorandum
Phase II Study of Intravesical Gemcitabine in Patients with Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
Study Coordinator(s) | Eila C. Skinner, M.D., Daniel P. Petrylak, M.D., Heinz- Josef Lenz, M.D. |
Participants | Members, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Pathologists |
Memorandum
Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
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 |
Memorandum
Tandem Autologous Stem Cell Transplantation For Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II
Study Coordinator(s) | Eileen P. Smith, M.D., Patrick J. Stiff, M.D., Louis S. Constine, M.D., Thomas M. Grogan, M.D. |
Participants | Limited Institutions: SWOG Approved Autologous BMT Facilities, Limited Institutions: BMT CTN Approved Autologous BMT Facilities |
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
Neoadjuvant Chemoradiation Therapy with Oxaliplatin and Capecitabine for Patients with Surgically Resectable Gastric Cancer: A Pilot Phase II Trial with Molecular Correlates
Study Coordinator(s) | Syed Ahmad, M.D., Lawrence P. Leichman, M.D., Lisa Kachnic, M.D., Scott A. Hundahl, M.D., Cecilia M. Fenoglio-Preiser, M.D., Charles D. Blanke, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, Radiation Oncologists, Surgeons |
Memorandum
A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
Action Codes | ER |
Study Coordinator(s) | Yuhchyau Chen, M.D., Ph.D, Kishan J. Pandya, M.D., Karen Kelly, M.D., Derick H.M. Lau, M.D.,Ph.D., Laurie E. Gaspar, M.D., Fred R. Hirsch, M.D.,Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists |
Memorandum
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
Study Coordinator(s) | Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States |
Memorandum
A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action Codes | ER |
Study Coordinator(s) | Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, 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 |
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
Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
Study Coordinator(s) | Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
Phase II Trial of Pemetrexed in Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Study Coordinator(s) | Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Wilbur A. Franklin, M.D., Rachel E. Sanborn, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989; IND-75,093) and Everolimus (RAD001; NSC-733504; IND-75,093) in Patients with Advanced Solid Tumors
Study Coordinator(s) | Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D., Patricia LoRusso, D.O., Jennifer Carew, Ph.D. |
Participants | Limited: Institutions Listed on the Title Page |
Revision #3
A Phase II Trial of Cytarabine and Clofarabine in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
Action Codes | ER |
Study Coordinator(s) | Anjali S. Advani, M.D., Jerald P. Radich, M.D., Marilyn L. Slovak, Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Action Codes | ER |
Study Coordinator(s) | Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - bevacizumab safety reports
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - cetuximab safety reports
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX
Action Codes | ER |
Study Coordinator(s) | Philip Gold, M.D., Anthony Shields, M.D.,Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum
A Phase II Study of Lenalidomide (Revlimid®) (NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Action Codes | ER |
Study Coordinator(s) | Mikkael A. Sekeres, M.D., M.S., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Coordinator(s) | Susanne M. Arnold, M.D. |
Participants | Members, NCORP, Affiliates |
Memorandum
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
Action Codes | ER |
Study Coordinator(s) | Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
Action Codes | ER |
Study Coordinator(s) | Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
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 |
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