Recruiting | Phase II
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for newly diagnosed advanced stage and recurrent chemo naive Sex Cord-Stromal tumors of the ovary.
The purpose of this study is to find out whether treatment with the drugs Paclitaxel and Carboplatin work better to control your cancer than treatment with the drugs Bleomycin, Etoposide and Cisplatin, which is the standard treatment for your type of cancer. Another purpose of this study is to find out what side effects are caused by treatment with these drug combinations and whether inhibin levels (a blood test) might be a good way to know how someone is responding to treatment.
- Study agents: Paclitaxel, Carboplatin, Bleomycin, Etoposide, Cisplatin
- ARM 1: Paclitaxel and Carboplatin IV (in a vein) every 21 days for 6 cycles as long as it is tolerated and effective
- ARM 2: Bleomycin IV (in a vein) to be given on day 1 every 3 weeks for 4 cycles (12 weeks), Etoposide IV daily for five days every 3 weeks for 4 cycles (12 weeks), Cisplatin IV daily for five days every 3 weeks for 4 cycles (12 weeks) as long as it is tolerated and effective.
After completion of study therapy, patients are followed for up to 10 years.
Key Participation Requirements:
19 years and older
Histologically confirmed ovarian stromal tumor (granulosa cell tumor, graulosa cell-theca cell tumor, Sertoli-Leydig cell tumor, steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules.
Patients with newly diagnosed Stage IIA – IV disease.
Must be enrolled within 8 weeks from surgery, OR have a biopsy proven recurrent disease of any stage and have never received chemotherapy.
Negative pregnancy test or agree to an effective means of birth control.
Must have adequate bone marrow function, liver function, and kidney function.
No signs of significant hearing loss.
Patients must have lung function tests with normal lung function.
Patients must be recovered from surgery, radiotherapy or chemotherapy.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.