Priority Lists
Protocol Posting of
Activations
Activation, effective 2/1/2014
Phase III Trial of Enzalutamide Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
| Action Codes | ER |
| Study Coordinator(s) | Amir Goldkorn, M.D. |
| Participants | CTSU |
Activation - Effective 2/1/14
Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
| Study Coordinator(s) | Jeffrey A. Zonder, M.D. |
| Participants | CTSU |
Closures
Permanent Closure - Effective 10/31/13
A Phase II Randomized Trial Comparing Standard and Low Dose Rituximab: Initial Treatment of Progressive Chronic Lymphocytic Leukemia in Elderly Patients Using Alemtuzumab and Rituximab
| Action Codes | ER |
| Study Coordinator(s) | Edward Libby, M.D. |
| Participants | CTSU |
| Closure Date | 2013-10-31 |
Permanent Closure effective 5/28/2013
S0000D, "A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT, Phase III Ancillary to S0000-SELECT
| Action Codes | ER |
| Study Coordinator(s) | M. Peter Lance, M.D., David S. Alberts, M.D., Achyut Battacharyya, M.D., Sylvan Green, M.D., Maria Elena Martinez, Ph.D. |
| Participants | Participating Study Centers listed in Appendix Section 19.1 |
| Closure Date | 2013-05-28 |
Temporary Closure - Effective 1/17/2014
A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
| Action Codes | ER |
| Study Coordinator(s) | Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D. |
| Participants | SWOG |
Amendments, Revisions, Memoranda
Revision #2
A Phase II/III Study of Intraperitoneal (IP) plus Intravenous (IV) Chemotherapy versus IV Carboplatin plus Paclitaxel in Patients with Epithelial Ovarian Cancer Optimally Debulked at Surgery following Neoadjuvant Intravenous Chemotherapy - NCIC-CTG
| Action Codes | ER |
| Study Coordinator(s) | Deborah Armstrong, M.D. |
| Participants | Members, NCORP, Affiliates |
Revision #7
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
| Action Codes | ER |
| 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 - OSI-774 Safety Reports
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 |
Revision #6
A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)
| Action Codes | ER |
| Study Coordinator(s) | Anjali S. Advani, M.D., Edward Copelan, MD, Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Abiraterone Acetate Safety Reports
Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
| Action Codes | ER |
| Study Coordinator(s) | Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
Memorandum - OSI-774 Safety Reports
Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
| Action Codes | ER |
| Study Coordinator(s) | Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU |
Memorandum - Drug Return
Phase II Trial of the Aurora Kinase A Inhibitor, MLN8237, in Peripheral T-Cell Non-Hodgkin Lymphoma
| Action Codes | NR |
| Study Coordinator(s) | Paul M. Barr, M.D., Jonathan W. Friedberg, M.D., Daruka Mahadevan, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, CTSU |
Revision #3
A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor (AI)-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer
| Action Codes | AC, ER |
| Study Coordinator(s) | Norah L. Henry, M.D.,Ph.D., Anne F. Schott, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Revision #3
A Randomized Phase III Study of Standard Cytarabine Plus Daunomycin (7+3) Therapy versus Idarubicin with High Dose Cytarabine (IA) with or without Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
| Action Codes | ER |
| Study Coordinator(s) | Guillermo Garcia-Manero, M.D., Jerald P. Radich, M.D., Min Fang, M.D.,Ph.D., John Pagel, MD, PhD |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Memorandum - Update to Worksheet for S1204 Monthly Summary
A Sero-Epidemiologic Survey and Cost-effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
| Action Codes | NR |
| Study Coordinator(s) | Scott Ramsey, M.D. |
| Participants | SWOG, NCORP, Affiliates, Medical Oncologists |
Memorandum - ABT-888 Safety Report
A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
| Action Codes | ER |
| Study Coordinator(s) | Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D. |
| Participants | SWOG |
Revision #2
A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
| Action Codes | ER |
| Study Coordinator(s) | Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D. |
| Participants | SWOG |
Memorandum - Updated specimen submission instructions
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
| Action Codes | NR |
| Study Coordinator(s) | Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY |
Memorandum - GSK2141795 Safety Report
"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
| Action Codes | ER |
| Study Coordinator(s) | Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Revision #2
"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
| Action Codes | ER |
| Study Coordinator(s) | Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - Master Forms Set Update
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
| Action Codes | NR |
| Study Coordinator(s) | Sikander Ailawadhi, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Revision #1
A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
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