Clinical Trial TitleA randomized phase II trial of radiation therapy and cisplatin alone or in combination with intravenous triapine in women with newly diagnosed bulky stage IB2, stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer.
Clinical Trial Protocol Description:
This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent.
- Have a life expectancy of greater than 20 weeks.
You will be excluded from the study if any of the following criteria apply to you:
- Have uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL).
This is a partial list of inclusion and exclusion criteria.