NRG-GY004

Clinical Trial Title Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Trial Status Closed to Enrollment
Start Date 06/23/2016
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Ovarian Cancer
Description This randomized phase III trial 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. 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 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 cancer.
Eligibility Criteria
  • Must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers
  •  Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy
  • ECOG Performance Status of 0, 1 or 2 (Karnofsky ≥ 60%)
  • Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to Grade 1
  • Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib. 
  • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and TSH within normal limits

Ineligibility Criteria

  • Have had chemotherapy or radiotherapy within 4 weeks
  • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease
  • Treated limited stage basal cell or squamous cell carcinoma of the skin
  • Carcinoma in situ of the breast or cervix
  • History of stroke or transient ischemic attack within six months.
  • Known HIV-positive individuals are ineligible

Treatment

ARM I: Patients may be treated with one of the three regimens per investigator discretion.

  • REGIMEN I: Patients receive carboplatin intravenously (IV) and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
  • REGIMEN II: Patients receive carboplatin IV on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
  • REGIMEN III: Patients receive carboplatin IV and pegylated liposomal doxorubicin hydrochloride IV on day 1. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive olaparib orally (PO) twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive olaparib PO BID and cediranib maleate PO once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
IRB Number Legacy IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02446600
Principal Investigator Colleen McCormick, MD
Contact Name Onoclogy Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org