Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer

Summary

This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Chemotherapy drugs 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 giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

Conditions

• Fallopian Tube Clear Cell Adenocarcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube Serous Adenocarcinoma
• Fallopian Tube Transitional Cell Carcinoma
• Fallopian Tube Undifferentiated Carcinoma
• Ovarian Clear Cell Adenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian Seromucinous Carcinoma
• Ovarian Serous Adenocarcinoma
• Ovarian Transitional Cell Carcinoma
• Ovarian Undifferentiated Carcinoma
• Primary Peritoneal Serous Adenocarcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Interventions

DRUG

Cediranib

Given PO

DRUG

Cediranib Maleate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Olaparib

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Topotecan

Given IV

DRUG

Topotecan Hydrochloride

Given IV

Sponsors & Collaborators

• Canadian Cancer Trials Group

  collaborator NETWORK

• NRG Oncology

  collaborator OTHER

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Jung-min Lee · 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

2016-05-03

Primary Completion

2023-06-12

Completion

2027-03-04

Countries

• United States
• Canada
• Japan
• Puerto Rico
• South Korea

Study Locations