A Phase III Study of Olaparib Alone or with Cediranib versus Standard Chemotherapy in Women with Recurrent Ovarian Cancer

Full 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 (NRG-GY004)(CIRB)

Purpose

Olaparib kills cancer cells by blocking the PARP protein, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more vulnerable to anticancer treatments. It is approved for treating some women with ovarian cancer. Cediranib is an investigational anticancer drug that inhibits the growth of the blood vessels that tumors need to grow and spread.

In this study, researchers are comparing olaparib alone, olaparib plus cediranib, and standard platinum-based chemotherapy in women with ovarian, fallopian tube, or primary peritoneal cancer that initially disappeared after platinum-based therapy but has come back. Patients will be randomly assigned to receive one of these treatments:

  • olaparib alone
  • olaparib plus cediranib
  • standard platinum-based chemotherapy

Olaparib and cediranib are each taken orally (by mouth), and platinum-based chemotherapy is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ovarian, fallopian tube, or primary peritoneal cancer that completely responded to prior platinum-based therapy but came back 6 or more months after treatment ended.
  • Patients must recover from the serious side effects of prior treatments before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. William Tew at 646-888-4220.

Protocol

16-132

Phase

III

Investigator

Co-Investigators