GY005 A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This study has two parts: A Phase II part and a Phase III part. The purpose of the Phase II part of the study is to compare any good and bad effects of using a combination of the investigational agents cediranib and olaparib, to using the standard chemotherapy, or cediranib alone, or olaparib alone. The Phase III study will follow the Phase II to confirm the effectiveness of a combination of cediranib and olaparib to the standard chemotherapy.
You are being asked to take part in this study because you have recurrent platinum-resistant or –refractory ovarian cancer, defined as cancer that returned within 6 months of completion of platinum-containing chemotherapy, or continued to get worse during platinum-containing chemotherapy.
Eligible patients will be randomly assigned, like the flip of a coin, to one of the following regimens: 1) usual chemotherapy, 2) olaparib and cediranib by mouth daily, 3) cediranib by mouth daily, or 4) olaparib by mouth daily. The physician will determine the number of cycles for the participants receiving usual chemotherapy. Participants will continue to take olaparib and/or cediranib until disease progression or intolerable side effects. All participants will then be followed for disease and overall status for up to 5 years.
08/11/2020 05:02 AM