Study ID: NRG GY005
Cediranib maleate and olaparib or cediranib maleate or standard non-platinum chemotherapy in treating patients with recurrent platinum-resistant or -refractory ovarian, fallopian tube or primary peritoneal cancer
Researchers are conducting a randomized clinical trial to determine if the experimental drug cediranib maleate and the FDA-approved Lynparza™ (olaparib) may stop the growth of tumor cells by blocking enzymes needed for cell growth. They are comparing the drug regimen to standard chemotherapy.
Eligible patients are grouped into three treatment studies: One group receives standard chemotherapy, another group receives cediranib maleate and olaparib, and the third group receives only cediranib maleate. Patients undergo follow-up care for up to five years.
This is a randomized treatment study to determine how well cediranib maleate and olaparib, and cediranib maleate alone, compare to non-platinum standard chemotherapy in patients diagnosed with recurrent ovarian, fallopian tube or primary peritoneal cancer and who are deemed platinum-resistant or -refractory.
Note: Phase II accrual was suspended in 2017. At the interim analysis in 2018, the Data Monitoring Committee voted to drop the single-agent olaparib arm. The Phase III trial will be continued with three arms: standard non-platinum chemotherapy, cediranib and olaparib, and cediranib alone. Phase II patients treated on one of these three arms will be included in the phase III trial.
Eligible patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings. Both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers.
Patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided the patient has a known deleterious germline BRCA1 or BRCA2 mutation.
Other inclusion/exclusion criteria apply.
Must have already undergone treatment for ovarian, fallopian tube or primary peritoneal cancer but the cancer has returned or has not responded to chemotherapy within six months of last platinum chemotherapy.