Gynecologic Cancer 264

April 26, 2017

Sponsor: Gynecologic Oncology Group

Number: 264

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II trial. Phase II trials: the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. This trial studies Paclitaxel and Carboplatin to see how well they work compared with Bleomycin Sulfate, Etoposide  Phosphate, and Cisplatin in treating patients with sex cord-ovarian stromal tumors (gastrointestinal) that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Who’s eligible:

• Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules].
• Patients must have newly diagnosed, stage IIA – IV disease and must be entered within eight weeks from surgery. Stage I, Stage II, and Stage III- The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV- The cancer has spread to distant parts of the body.
• Patients may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria (a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment), they may have no measurable residual disease, or  they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy. Cytotoxic chemotherapy is chemotherapy that is toxic to living cells.
• Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2.
• Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control.
• This study is for women age 18 and older.

Available at: The Hospital of Central Connecticut, Hartford Hospital.