Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02345265
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Fallopian Tube Carcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Ovarian Carcinoma
  • Ovarian High Grade Endometrioid Adenocarcinoma
  • Ovarian High Grade Serous Adenocarcinoma
  • Primary Peritoneal Carcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy of tumor
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cediranib Maleate — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography Test — PROCEDURE
    Undergo echocardiogram
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI scan
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Olaparib — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial studies how well olaparib and cediranib maleate work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement (recurrent). Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
May 23, 2016
Status verified
Mar 2026
Primary completion
Jul 7, 2022
Completion
Mar 4, 2027

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib and cediranib maleate)
    Patients receive olaparib PO BID and cediranib maleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a biopsy of tumor, blood sample collection, MUGA or echocardiogram, and CT scan or MRI scan throughout the study.

Primary Outcome Measure

Progression-Free Survival (PFS) by HRR Status in Platinum-Sensitive Ovarian Cancer [ Time Frame: Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first, assessed up to 32 months. ]

Locations (20)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Keck Medical Center of USC PasadenaPasadenaCalifornia91105-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Moffitt Cancer CenterTampaFlorida33612-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
NCI - Center for Cancer ResearchBethesdaMaryland20892-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mayo Clinic in RochesterRochesterMinnesota55905-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Phoenix, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZMayo Clinic in Arizona· Scottsdale, AZCity of Hope Comprehensive Cancer Center· Duarte, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAKeck Medical Center of USC Pasadena· Pasadena, CA

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