Trial & Business Updates:

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Closures

CTSU/E2108Phase III Intergroup

Permanent Closure to Accrual - Effective 7/23/15

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer.
Action CodesER
Study Coordinator(s)Christine Lee, M.D.
ParticipantsCTSU
Closure Date2015-07-23

Amendments, Revisions, Memoranda

C10404Phase II Intergroup

Memorandum - Master Forms Sets Available from SWOG website

"A Genetic Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia."
Action CodesNR
Study Coordinator(s)John E. Godwin, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, Pathologists
S0635Phase II

Memorandum - Drug Order Form & Holiday Closure

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 CodesNR
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S1007Phase III Intergroup

Memorandum - CIRB Memo and Form Update

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 CodesNR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1014Phase II

Memorandum 1 of 2 - Abiraterone Acetate Safety Report

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER, NR
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1014Phase II

Memorandum 2 of 2 - Drug Order Form & Holiday Closure

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER, NR
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1202Phase III

Memorandum - Drug Order Form & Holiday Closure

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 CodesNR
Study Coordinator(s)Norah L. Henry, M.D.,Ph.D., Anne F. Schott, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S1203Phase III

Memorandum - MCF Correction

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 CodesNR
Study Coordinator(s)Guillermo Garcia-Manero, M.D., Jerald P. Radich, M.D., Min Fang, M.D.,Ph.D., John Pagel, MD, PhD
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1216Phase III

Memorandum - Drug Order Form & Holiday Closure

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 CodesNR
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY
S1300Phase II Intergroup

Memorandum - Drug Order Form & Holiday Closure

A Randomized, Phase II Trial of Crizotinib Plus Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive Non-Squamous NSCLC Patients Who Have Progressed Systemically After Previous Clinical Benefit from Crizotinib Monotherapy
Action CodesNR
Study Coordinator(s)D. Ross Camidge, M.D., Ph.D, Tianhong Li, M.D., Ph.D, Robert C. Doeble, M.D., Ph.D
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1304Phase II Intergroup

Memorandum - Updated Drug Order Form and Holiday Closure

A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
Action CodesER, NR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1304Phase II Intergroup

Revision #5

A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
Action CodesER, NR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1312Phase I

Memorandum - Additional Slot on Dose Level 3

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 CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page
S1313Phase I-II

Memorandum - Drug Order Form & Holiday Closure

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 CodesNR
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1400Phase II-III Intergroup

Memorandum 1 of 2 - Updated Forms

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER, 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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1400Phase II-III Intergroup

Memorandum 2 of 2 - MEDI4736 Safety Reports (for S1400A)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER, 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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1403Phase II-III

Memorandum - Drug Order Form & Holiday Closure

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)
Action CodesNR
Study Coordinator(s)Sarah B. Goldberg, MD, MPH, Rogerio C. Lilenbaum, M.D., Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1406Phase II

Memorandum - Drug Order Form & Holiday Closure

Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Action CodesNR
Study Coordinator(s)E. Scott Kopetz, M.D., Heinz- Josef Lenz, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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