Gynecologic Cancer NRG GY005 - Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor: NRG Oncology

Number: GY005

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 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. Drugs used in chemotherapy 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.

Who’s eligible:

Patients must have measurable stage III (cancer which has spread from the site of the primary [original] tumor only to surrounding tissue, lymph nodes), measurable stage IVA, stage IVB (or the development of secondary malignant growths at a distance from a primary site of cancer, with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma.

Measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1-a set of published rules that define when tumors in cancer patients improve ["respond"], stay the same ["stabilize"], or worsen ["progress"] during treatment). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray. Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI.

For additional information about this study, please call the Cancer Clinical Research Office at (860) 972-4700.

Available at: The Hospital of Central Connecticut, Hartford Hospital.