PCRC_GY004

A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This randomized 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.

Inclusion Criteria:
•Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with known deleterious germline BRCA1 or BRCA2 mutation on a clinical assay with an ovarian, primary peritoneal, or fallopian tube cancer of the following other Mullerian histologies are also eligible: clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma; Myriad testing will be accepted; if testing for germline BRCA is done by other organizations, genetic consultation report from a qualified medical professional listing the mutation and confirming that the laboratory results showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement is required; please collect a copy of Myriad or other BRCA mutational analysis (positive or VUS or negative) reports
◦Platinum-sensitive disease defined as no disease progression for > 6 months after last receipt of platinum-based therapy
◦Patients must have had a complete response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy; patients who have no measurable disease following their initial cytoreductive surgery and have no evidence of disease progression for at least 6 months following their last receipt of platinum-based therapy or their date of surgery (whichever is later) will also be considered eligible
Prior therapy:
◦Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy
◦Patients may have received an unlimited number of platinum-based therapies in the recurrent setting
◦Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line
◦Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
◦Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor
◦Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable

Phase III
NCT02446600
Oncology
Gynecologic
Paul Montgomery, M.D.
NRG
Brenda Fisher

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.