|Clinical Trial Title||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|
|Trial Status||Closed to Enrollment|
|Location||Doctors & Locations|
|Trial Type||Cancer - Adult Oncology|
|Specific Condition||Ovarian Cancer|
|Description||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.|
ARM I: Patients may be treated with one of the three regimens per investigator discretion.
ARM II: Patients receive olaparib orally (PO) twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive olaparib PO BID and cediranib maleate PO once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|IRB Number||Legacy IRB|
|Principal Investigator||Colleen McCormick, MD|
|Contact Name||Onoclogy Clinical Research|