A randomized phase III trial of paclitaxel plus carboplatin versus ifosfamide plus paclitaxel in chemotherapy- naive patients with newly diagnosed stage I-IV, persistent or recurrent carcinosarcoma (mixed mesodermal tumors) of the uterus or ovary: GOG-0261.
The purpose of this study is to compare the drugs Carboplatin and Paclitaxel to a standard treatment for this type of cancer. Based on previous research, it is thought that these two drugs may be as effective as the standard treatment with fewer side effects. Participants will be asked to take the chemotherapy drugs for 6-10 total treatments, given once every 21 days, for a total of approximately 18-30 weeks.
This study is also interested in collecting samples of participant's tumor tissue and blood for future research. Participants and/or their insurance provider will need to pay for some or all of the costs of treating their cancer in this study.
In general, this study is looking for participants who:
- Are age 18 years or older.
- Have a negative serum pregnancy test as well as an acceptable form of contraception in place.
- Have newly diagnosed stage I-IV, persistent or recurrent uterine carcinosarcoma for which they are chemotherapy naïve.
- May have received prior adjuvant external beam radiation therapy and/or vaginal brachytherapy.
- Are at least four weeks from the completion of radiotherapy prior to beginning protocol chemotherapy.
- Have either measurable or non-measurable disease.
Janet L. Osborne, M.D.
Carilion GYN Oncology Associates