A Phase I/II Study of Paclitaxel, Cisplatin, and ABT-888 (Velaparib) to Treat Advanced, Persistent, or Recurrent Cervical Cancer

Protocol
11-131
Full Title
A Limited Access Phase I/II Trial of Paclitaxel, Cisplatin, and CTEP Supplied Agent ABT-888 (Velaparib) (IND#77840, NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix (GOG-0076HH)
Phase
I/II
Purpose

The purpose of this Gynecologic Oncology Group study is to evaluate the safety and effectiveness of various doses of an investigational drug called ABT-888 (veliparib) when it is given with paclitaxel and cisplatin in patients with cervical cancer that is advanced or has returned or persisted despite prior treatment. Various doses of ABT-888 will be evaluated in the phase I portion of the trial, while its effectiveness in combination with paclitaxel and cisplatin will be assessed in the phase II portion.

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. ABT-888 may make paclitaxel/cisplatin treatment work more effectively.

Eligibility

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

  • Patients must have stage IVB, recurrent, or persistent cervical cancer.
  • At least 6 weeks must have passed since completion of chemoradiation or major surgery and 3 weeks since any radiation therapy alone and entry into the study.
  • Patients may not have had prior treatment with ABT-888 or other PARP inhibitors.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario Leitao at 212-639-3987.

Disease(s)
Cervical Cancer
Locations
Related Diseases