Trial & Business Updates:

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Priority Lists

Activations

Reactivation

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 CodesNR
Study Coordinator(s)Scott Ramsey, M.D.
ParticipantsSWOG, NCORP, Affiliates, Medical Oncologists

Closures

S0819Phase III Intergroup

Permanent Closure Effective 5/1/15 and Revision #16

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Action CodesER
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU Institutions in the United States
Closure Date2015-05-01
S1221Phase I-II

Temporary Closure

"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 CodesNR
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.
ParticipantsLimited: Institutions Listed on the Title Page

Amendments, Revisions, Memoranda

C10404Phase II Intergroup

Memorandum - Transition to Medidata Rave

"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
S0805Phase II

Revision #18

Phase II Study of Combination of Hyper-CVAD and Dasatinib with or without Allogeneic Stem Cell transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL)
Action CodesNR
Study Coordinator(s)Farhad Ravandi, M.D., Susan O'Brien, M.D., Stephen J. Forman, M.D., Chul S. Ha, M.D., Jeffrey Y.C. Wong, M.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, BMT CTN
S1007Phase III Intergroup

Revision #11

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
S1013Phase II

Revision #5

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 CodesFBR, NR
Study Coordinator(s)Siu-Fun Wong, Pharm.D., Carol M. Moinpour, Ph.D., James L. Wade, III, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1203Phase III

Revision #6

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 CodesFBR
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

Revision #4

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 CodesNR
Study Coordinator(s)Scott Ramsey, M.D.
ParticipantsSWOG, NCORP, Affiliates, Medical Oncologists
S1304Phase II Intergroup

Revision #4

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
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S1400Phase II-III Intergroup

Memorandum - Palbociclib Safety Report (for S1400C)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER
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
  • 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