Research & Clinical Trials

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NCT01116648

Phase I/II Study of Cediranib and Olaparib in Combination for Treatment of Recurrent Papillary-Serous Ovarian, Fallopian Tube, or Peritoneal Cancer or for Treatment of Recurrent Triple-Negative Breast Cancer

Update: This study is active but no longer recruiting subjects

Study identifier: NCT01116648

Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Olaparib (AstraZeneca)

Eligibility

PHASE II:

  • Participants must have histologically or cytologically Grade 2 or 3 (high-grade) papillary-serous or endometrioid epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer; participants with epithelial ovarian, primary peritoneal, or fallopian tube cancers of other high-grade histologies who carry a known deleterious BRCA germline mutation by standard clinical testing (Myriad BRAC Analysis) will also be considered eligible
  • Participants in the Phase II portion of the trial must have measurable disease by RECIST 1.1 criteria
  • Breast cancer participants must have measurable disease by RECIST criteria

PRIOR THERAPY PHASE II:

  • Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy
  • Prior hormonal-based therapy for ovarian, primary peritoneal serous, or fallopian tube cancer is acceptable
  • Patients may not have previously received a PARP-inhibitor. Prior treatment with BSI-201 is allowed
  • Patients may not have had a prior anti-angiogenic agent in the recurrent setting
  • Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting
  • Patients may have received an unlimited number of platinum-based therapies in the recurrent setting
  • Patients should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence; patients must have had a prior response while on the platinum-containing regimen and cannot have experienced disease progression while receiving platinum

Type of study:

Phase II study

Treatment:

Breast cancer patients who enroll will receive both cediranib and olaparib.

Study sites:

California
Los Angeles
Cedars-Sinai Medical Center
Contact: M. W. Audeh 310-423-1188 william.audeh@cshs.org

Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Contact: Gini F. Fleming 773-702-6712 gfleming@medicine.bsd.uchicago.edu

Decatur
Decatur Memorial Hospital
Contact: James L. Wade 217-876-4740 kcheek@dmhhs.org

Evanston
Evanston CCOP-NorthShore University HealthSystem
Contact: Bruce E. Brockstein 847-570-1381 bbrockstein@northshore.org

Harvey
Ingalls Memorial Hospital Recruiting
Contact: Sulochana D. Yalavarthi 708-339-4800 sulochana2001@hotmail.com

Maywood
Loyola University Medical Center
Contact: Joseph I. Clark 708-226-4357 jclark@lumc.edu

Peoria
Illinois CancerCare-Peoria
Contact: James A. Knost 309-243-3000 jknost@illinoiscancercare.com

Springfield
Southern Illinois University
Contact: Krishna A. Rao 217-545-5817 krao@siumed.edu

Central Illinois Hematology Oncology Center
Contact: Sachdev P. Thomas 309-243-3000 sthomas@illinoiscancercare.com

Indiana
Fort Wayne
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Contact: Sreenivasa R. Nattam 260-484-8830 ledgar@fwmoh.com

Maryland
Baltimore
Johns Hopkins University
Contact: Deborah K. Armstrong 410-614-2743 darmstro@jhmi.edu

University of Maryland Greenebaum Cancer Center
Contact: Martin J. Edelman 800-888-8823 medelman@umm.edu

Massachusetts
Boston
Beth Israel Deaconess Medical Center
Contact: Mary F. Bussey 617-667-1395 mbuss@bidmc.havard.edu

Dana-Farber Cancer Institute
Contact: Joyce F. Liu 617-632-5269 joyce_liu@dfci.harvard.edu

Massachusetts General Hospital Cancer Center
Contact: Michael J. Birrer 617-724-4800 mbirrer@partners.org

Newton
Newton-Wellesley Hospital
Contact: Caroline C. Block 617-658-6000 cblock@partners.org

Michigan
Ann Arbor
University of Michigan University Hospital
Contact: Maha H. Hussain 800-865-1125 mahahuss@umich.edu

Missouri
Saint Louis
Saint John's Mercy Medical Center
Contact: Bethany G. Sleckman 913-948-5588 Bethany.Sleckman@Mercy.Net

New York
New York
Memorial Sloan Kettering Cancer Center
Contact: William P. Tew 212-639-6555 teww@mskcc.org

Wisconsin
Froedtert and the Medical College of Wisconsin
Contact: Stuart J. Wong 414-805-4380 swong@mcw.edu

Page updated 07/08/13