NRG-GY005/COCOS: 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 p

Protocol: 
AAAR3339
Phase: 
II/III

NRG-GY005/COCOS: 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 p

This study has two parts: A Phase II part and a Phase III part. You are being
asked to participate in the Phase II part of the study. 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. There is no
placebo in this study. Cediranib is an experimental drug that may help keep
cancer cells from growing by affecting their blood supply. Olaparib is a drug
that may stop cancer cells from growing abnormally. Olaparib by itself has been
approved by the Food and Drug Administration (FDA) for use in women with
advanced ovarian cancer with BRCA1 andBRCA2 mutation who have been treated with
three or more different chemotherapy treatments. The combination of olaparib and
cediranib is investigational. These five drugs have been used in other research
studies in ovarian cancer, and information from those other research studies
suggest that these may help to keep cancer from growing. The addition of
cediranib to olaparib could shrink your cancer but it could also cause side
effects. This study will allow the researchers to know whether this different
approach using two study drugs is better, the same, or worse than either drug
alone or the usual chemotherapy approach.
Standard chemotherapy drugs that are already FDA-approved for use in recurrent
ovarian cancer include paclitaxel, topotecan, or pegylated liposomal doxorubicin
(PLD) used alone or in combination with bevacizumab. Bevacizumab is not allowed
as part of standard chemotherapy on this study.

Are you Eligible? (Inclusion Criteria)

1. 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 that the patient has a known deleterious germline BRCA1 or BRCA2
mutation identified through testing at a clinical laboratory.
2. Patients should have disease that has progressed by imaging while receiving
platinum or had recurrence within 6 months of the last receipt of platinum-based
chemotherapy
3. No more than 3 prior treatment regimens (including primary therapy; no more
than 1 prior non-platinum based therapy in the platinum-resistant/-refractory
setting).

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States