A Phase II Study of Paclitaxel/Carboplatin versus Bleomycin/Etoposide/Cisplatin for Patients with Advanced Ovarian Stromal Tumors Who Have Not Received Chemotherapy

Protocol
13-177
Full Title
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary (GOG 264)
Phase
II
Disease Status
Relapsed/Refractory
Purpose

The combination of the anticancer drugs bleomycin, etoposide, and cisplatin is the standard therapy for treating ovarian stromal tumors. However, this trio of chemotherapy drugs causes significant side effects and is associated with a high rate of cancer recurrence. Doctors are therefore seeking more effective, less toxic therapies.

In this Gynecologic Oncology Group study, researchers are comparing treatment with paclitaxel and carboplatin to the standard therapy. Patients will be randomly assigned to receive paclitaxel/carboplatin or bleomycin/etoposide/cisplatin. All of these drugs are given intravenously (by vein).

As part of this study, investigators will also be assessing the usefulness of measuring blood levels of a protein called inhibin to determine how well a patient is responding to treatment.

Eligibility

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

  • Patients must be newly diagnosed with a stage IIA-IV ovarian stromal tumor and enter the study within 8 weeks of surgery.
  • Patients with recurrent disease may be eligible to participate if they have not yet received chemotherapy.
  • This study is open to patients age 18 and older.

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

Disease(s)
Ovarian Cancer
Locations
Related Diseases