Gynecologic Cancer NRG-004

April 26, 2017

Sponsor: National Cancer Institute (NCI)

Number: NRG-004

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial that 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. Phase III trials are new treatments that have worked well in a small number of patients with a disease. 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 (lining of the abdomen) 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 (lining of the abdomen) cancer.

Who’s eligible:

• Patients must have platinum-sensitive (the recurrence of active disease in a patient who has achieved a documented response to initial platinum-based treatment and has been off therapy for an extended period of time) recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers.
• 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 (tumor suppressor genes, or antioncogenes) identified through testing at a clinical laboratory.
• Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for > 6 months after last receipt of platinum-based therapy.
• Patients must have had a complete clinical response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy.
• Patients who have no measurable disease following their initial cytoreductive surgery (procedure used to remove tumors) and have no evidence of disease progression for at least 6 months following their last receipt of platinum-based therapy or their date of surgery will also be considered eligible. Whichever is later, therapy or surgery, makes the patient eligible.
• This study is for women 18 or older.

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