Trial & Business Updates:

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Priority Lists

Activations

Re-Activation

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
Action CodesER
Study Coordinator(s)Charles Schiffer, M.D.
ParticipantsCTSU
S1221Phase I-II

Activation

"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.
ParticipantsLimited: Institutions Listed on the Title Page

Closures

S1106Phase II Intergroup

Permanent Closure to accrual effective 6/26/13

A Randomized Phase II Trial of R-HCVAD-MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients
Action CodesER
Study Coordinator(s)Steven Bernstein, M.D., Robert Chen, M.D., Stephen J. Forman, M.D., Louis S. Constine, M.D., Lisa M. Rimsza, M.D.
ParticipantsCTSU
Closure Date2013-06-26

Amendments, Revisions, Memoranda

OV21Phase II-III

Memorandum - Oustanding Data

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 CodesNR
Study Coordinator(s)Deborah Armstrong, M.D.
ParticipantsMembers, NCORP, Affiliates
S1005Phase II

Memorandum - Condensed Risk List and CAEPR Update

A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
Action CodesNR
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D.
ParticipantsMedical Oncologists, Members, NCORP, Affiliates
S1007Phase III Intergroup

Revision#7

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 CodesER
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
S1107Phase II

Memorandum - ARQ 197 Safety Report

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
Action CodesER
Study Coordinator(s)Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
S1117Phase II Intergroup

Memorandum - Form Update

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)
Action CodesNR
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1200Phase III

Funding Memorandum

Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer
Action CodesNR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page
S1203Phase III

Memorandum - Form Change

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
S1206 (8811)Phase II

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 CodesER
Study Coordinator(s)Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D.
ParticipantsSWOG
S1216Phase III

Memorandum - TAK-700 Safety Reports

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 CodesER
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
  • 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