Gynecologic Cancer NRG-005

April 26, 2017

Sponsor: National Cancer Institute (NCI)

Number: NRG-005

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II/III trial. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. This trial studies how well Cediranib Maleate and Olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and Olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Chemotherapy drugs 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 giving Cediranib maleate and Olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

Who’s eligible:

  • Patients must have histologically (tissue microscopically examined) or cytologically (fluid cells microscopically examined) confirmed ovarian cancer, peritoneal (lining of the abdomen) 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 (tumor suppressor genes, or antioncogenes) mutation identified through testing at a clinical laboratory.
  • Patients should have recurrent platinum-resistant (chemotherapy-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. CA125 is a substance found in the blood, called a glycoprotein (a sugar associated protein).
    • Phase II study: measurable disease by RECIST 1.1 criteria (a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment); 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 (chemotherapy-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. An anti-angiogenic agent is a substance that inhibits the growth of new blood vessels, to prevent the development of new tumors.
  • This study is for women 18 or older.

Available at: The Hospital of Central Connecticut, Hartford Hospital.

Cancer Clinical Research Office