Priority Lists
Protocol Posting of
Activations
Activation - Effective 4/1/2015
“A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation.”
| Action Codes | ER |
| Study Coordinator(s) | David E. Piccioni, MD, PhD |
Re-activation 3/16/15 (superseded by temporary closure on 4/1/15)
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 | ER, NR |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Activation - Effective 3/25/15
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone In Treatment-Naïve Patients With Advanced, EGFR Mutation Positive Non-Small Lung Cancer (NSCLC)
| Study Coordinator(s) | Sarah B. Goldberg, MD, MPH, Rogerio C. Lilenbaum, M.D., Katerina Politi, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Permanent Closure - Effective 4/1/15
A Randomized Phase II Pilot Study Prospectively Evaulating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
| Study Coordinator(s) | Syma Iqbal, M.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
| Closure Date | 2015-04-01 |
Temporary Closure - Effective 3/16/15
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
| Study Coordinator(s) | Richard D. Kim, M.D., Anthony El-Khoueiry, M.D. |
| Participants | Members, NCORP, Affiliates |
| Closure Date | 2015-05-15 |
Temporary Closure - Effective 4/1/15
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 | ER, NR |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Amendments, Revisions, Memoranda
Update #9 - Accessible from the SWOG Protocol Abstract Page
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
| Action Codes | ER, NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
Funding Memorandum
Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction."
| Study Coordinator(s) | John Sarantopolous, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Funding Memorandum
A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)
| Study Coordinator(s) | Anjali S. Advani, M.D., Edward Copelan, MD, Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #10
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
| Action Codes | NR |
| Study Coordinator(s) | Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Funding Memorandum
A Phase II Prospective Study of Epidermal Growth Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-induced Skin Toxicities
| Action Codes | NR |
| Study Coordinator(s) | Siu-Fun Wong, Pharm.D., Carol M. Moinpour, Ph.D., James L. Wade, III, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Funding Memorandum
Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
| Action Codes | ER, NR |
| Study Coordinator(s) | Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - AZD6244 Safety Report
Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
| Action Codes | ER, NR |
| Study Coordinator(s) | Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Funding Memorandum
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
| Participants | Affiliates, NCORP, Medical Oncologists, Members, CTSU |
Funding Memorandum
A Randomized Phase II Pilot Study Prospectively Evaulating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
| Study Coordinator(s) | Syma Iqbal, M.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Funding Memorandum
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 | NR |
| Study Coordinator(s) | Norah L. Henry, M.D.,Ph.D., Anne F. Schott, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Funding Memorandum
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)
| 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 |
Funding Memorandum
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
| Action Codes | NR |
| Study Coordinator(s) | Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph |
| Participants | CTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP |
Memorandum
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
| Action Codes | NR |
| Study Coordinator(s) | Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph |
| Participants | CTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP |
Funding Memorandum
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
| Study Coordinator(s) | Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD |
| Participants | Limited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Funding Memorandum
"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."
| 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 |
Funding Memorandum
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 | ER |
| Study Coordinator(s) | Sikander Ailawadhi, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Memorandum - Clarification of Full Assigned Dose
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 | ER |
| Study Coordinator(s) | Sikander Ailawadhi, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Revision #3
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 | ER |
| Study Coordinator(s) | Sikander Ailawadhi, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
Funding Memorandum
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
| Study Coordinator(s) | Richard D. Kim, M.D., Anthony El-Khoueiry, M.D. |
| Participants | Members, NCORP, Affiliates |
Funding Memorandum
A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Michaela Liedtke, MD |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum 1 of 2 - Slot Reserved (March 20, 2015) on Dose Level 2
A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Michaela Liedtke, MD |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum 2 of 2 - Slot Re-Opened (March 25, 2015) on Dose Level 2
A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Michaela Liedtke, MD |
| Participants | Limited: Institutions Listed on the Title Page |
Funding Memorandum
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 | ER, NR |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - PEGPH20 Safety Reports
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 | ER, NR |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Funding Memorandum
Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
| Action Codes | NR |
| Study Coordinator(s) | Robert S. Krouse, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Revision #1
Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
| Action Codes | NR |
| Study Coordinator(s) | Robert S. Krouse, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Funding Memorandum
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Updated Lab Kit Order Form and Lab Manual
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #2
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Funding Memorandum
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
| Study Coordinator(s) | Alain P. Algazi, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU |
Funding Memorandum (S1400, S1400A, S1400B, S1400C, S1400D)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 1 of 4 - Regarding FDA Approval of Nivolumab
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 2 of 4 - Request for Application for New Drugs
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 3 of 4 - MEDI4736 Safety Report (for S1400A)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum 4 of 4 - Palbociclib Safety Report (for S1400C)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER, NR |
| Study Coordinator(s) | Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
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