Phase II/III of Cediranib and Olaparib or Standard Chemotherapy

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)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Quintiliani, Jennifer; Jobson, Gillian S

    Trial Phone: 321.843.2026 ; 321.841.2285

  • IRB No: GY005

    Protocol Abbrev: GY005

    Principal Investigator: Veronica L Schimp, DO

    Sub Investigators: Moroose, Rebecca MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: NRG GY005

    Treatment: Chemotherapy; Oncology: 3rd line/Refractory

    Applicable Disease Sites: Ovarian, Fallopian Tube or Primary Peritoneal Cancer

    Therapies Involved: Cediranib and Olaparib ID: NCT02502266

  • Objective

    To assess the efficacy and identify (in)active arm(s) of the combination of cediranib (cediranib maleate) and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by progression-free survival (PFS) in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer.

  • Key Eligibility

    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 that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory

    Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease
    Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable
    Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen [CA]125 >= 2 x upper limit of normal [ULN])
    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); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit
    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 PARP-inhibitor
    Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2