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Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Title A Phase III study 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
Therapeutic Area Ovarian Cancer
Principal Investigator Young Kim, MD
Min Age 18 Years
Gender Female
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT02446600

Overview

The purpose of this study is to compare the effect on ovarian cancer of using either olaparib by itself or the combination of cediranib and olaparib to the usual chemotherapy given for ovarian cancer.

Study Details

Inclusion Criteria

  • Recurrent ovarian, fallopian tube, or primary peritoneal cancer that recurred more than 6 months after the last platinum-based chemotherapy
  • Ability to swallow pills
  • Adequately controlled blood pressure and the willingness to check and record blood pressure daily

Exclusion Criteria

  • No pregnant or nursing women<
  • No prior treatment with a PARP inhibitor
  • No complicating diseases or disorders including but not limited to stroke, heart disease, other cancers, or active infections

Study Requirements

Subjects will come to clinic for screening tests including a physical exam, vitals, blood and urine tests, genetic test (BRCA1/2), echocardiogram (for subjects at risk for cardiac side effects), CT scan, and a questionnaire about symptoms and overall health. Once it is confirmed that subjects are eligible to participate, they will be randomized to one of 3 arms: standard chemotherapy (which will be one of 3 regimens chosen by the study doctor), olaparib alone, or olaparib + cediranib. Olaparib and cediranib are pills that can be swallowed. Other study drugs (carboplatin, paclitaxel, doxil, and gemzar) are given as an infusion in a vein. Study drug regimens will be given in cycles (either 21 days or 28 days long). Subjects will come to the hospital every cycle for physical exams, blood, and urine tests. Subjects randomized to olaparib alone will be required to keep a pill diary and write down when they take the study drug at home. Subjects randomized to olaparib + cediranib will be required to keep a pill diary as well as measure and record their blood pressure every day. Subjects will be asked to fill out questionnaires about their symptoms and overall health every 3 months. If subjects are at a high risk for cardiac side effects, they’ll have echocardiograms every 3 or 4 months.