A Phase III Study of Rucaparib after Platinum-Based Chemotherapy in Women with High-Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
14-067
Full Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Phase
III
Purpose

Rucaparib is an investigational drug that 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. In this study, researchers want to see if giving rucaparib to women with ovarian, fallopian tube, or primary peritoneal cancer whose tumors shrank with platinum-based chemotherapy can reduce the chance that the cancer will spread or come back.

Patient will be randomly assigned to receive rucaparib (two-thirds of the patients) or a placebo (the other one-third). The rucaparib in this study is being given as a tablet that can be taken orally (by mouth).

Doctors also want to see if certain biomarkers, such as a patient’s BRCA mutation status, affect response to treatment.

Eligibility

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

  • Patients must have high-grade ovarian, fallopian tube, or primary peritoneal cancer that responded to two or more prior regimens of platinum-containing chemotherapy.
  • At least 2 weeks must pass between completion of prior therapy and entry into the study, and patients must have recovered from any serious side effects.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Katherine M. Bell-McGuinn at 646-888-4221.

Disease(s)
Related Diseases