Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02446600 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 579
Last updated 2026-05-04
Summary
This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Conditions
- Fallopian Tube Clear Cell Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Fallopian Tube Undifferentiated Carcinoma
- Ovarian Clear Cell Adenocarcinoma
- Ovarian Endometrioid Tumor
- Ovarian Seromucinous Carcinoma
- Ovarian Serous Tumor
- Ovarian Transitional Cell Carcinoma
- Ovarian Undifferentiated Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Ovarian Endometrioid Adenocarcinoma
- Recurrent Primary Peritoneal Carcinoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- DRUG
-
Given IV
- DRUG
-
Cediranib Maleate
Given PO
- PROCEDURE
-
Computed Tomography
Undergo CT
- PROCEDURE
-
Echocardiography Test
Undergo ECHO
- DRUG
-
Given IV
- DRUG
-
Gemcitabine Hydrochloride
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Multigated Acquisition Scan
Undergo MUGA
- DRUG
-
Given PO
- DRUG
-
Given IV
- DRUG
-
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
- OTHER
-
Pharmacological Study
Correlative studies
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator OTHER
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Joyce F Liu · NRG Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-28
- Primary Completion
- 2020-02-23
- Completion
- 2027-03-04
Countries
- United States
- Canada
- Japan
- South Korea
Study Locations
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