A Phase III Study of Carboplatin/Paclitaxel with or without Veliparib in Women with Previously Untreated Stage III/IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Full Title

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (GOG 3005)

Purpose

Carboplatin and paclitaxel are standard chemotherapy drugs used to treat high-grade serous ovarian, fallopian tube, or primary peritoneal cancers. Despite this treatment, however, the cancer often comes back. In this study, researchers are evaluating the effectiveness of adding the investigational drug veliparib to carboplatin and paclitaxel chemotherapy, both during chemotherapy treatment and afterward, with veliparib used alone as maintenance therapy to keep the cancer from growing.

Veliparib (also known as ABT-888) kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer drugs. Veliparib is taken orally (by mouth), while carboplatin and paclitaxel are given intravenously (by vein).

In this study, patients will be randomly assigned to one of three groups:

  • One group will have carboplatin/paclitaxel chemotherapy plus a placebo (inactive pill), followed by a placebo as maintenance therapy.
  • The second group will have carboplatin/paclitaxel chemotherapy plus veliparib, followed by a placebo as maintenance therapy.
  • The third group will have carboplatin/paclitaxel chemotherapy plus veliparib, followed by veliparib as maintenance therapy.

Eligibility

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

  • Patients must have newly diagnosed stage III or IV high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
  • 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. Carol Aghajanian at 646-888-4217.

Protocol

15-241

Phase

III

Investigator

Co-Investigators

Locations