Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01116648
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Fallopian Tube Carcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Serous Surface Papillary Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo optional tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cediranib Maleate — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Olaparib — DRUG
    Given PO

Study Details

This partially randomized phase I/II trial studies the side effects and the best dose of cediranib maleate and olaparib and to see how well they work compared to olaparib alone in treating patients with ovarian, fallopian tube, peritoneal, or triple-negative breast cancer that has returned after a period of improvement (recurrent). Cediranib maleate may help keep cancer cells from growing by affecting their blood supply. Olaparib may stop cancer cells from growing abnormally. The combination of cediranib maleate and olaparib may be safe, tolerable and/or effective in treating patients with recurrent ovarian, fallopian tube, or peritoneal cancer or recurrent triple-negative breast cancer.

Key Dates

Start date
Apr 14, 2010
Status verified
Mar 2026
Primary completion
Oct 31, 2018
Completion
Mar 4, 2027

Study Design

Enrollment
155 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (cediranib maleate and olaparib)
    Patients receive cediranib maleate PO QD and olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection on the trial. Patients may also optionally undergo a tissue biopsy on the trial.
  • Active Comparator: Arm II (olaparib)
    Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection on the trial. Patients may also optionally undergo a tissue biopsy on the trial.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) [ Time Frame: At 28 days ]

Locations (14)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
NorthShore University HealthSystem-Evanston HospitalEvanstonIllinois60201-
Fort Wayne Medical Oncology and Hematology Inc - Jefferson BoulevardFort WayneIndiana46804-
Fort Wayne Medical Oncology and Hematology Inc-ParkviewFort WayneIndiana46845-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
National Cancer InstituteRockvilleMaryland20850-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Massachusetts General HospitalCharlestownMassachusetts02129-
Newton-Wellesley HospitalNewtonMassachusetts02462-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILNorthShore University HealthSystem-Evanston Hospital· Evanston, ILFort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard· Fort Wayne, INFort Wayne Medical Oncology and Hematology Inc-Parkview· Fort Wayne, INJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MD

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