A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2, or Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer
Patients are asked to take part in this study because they have newly diagnosed cervical or vaginal cancer for which surgical treatment is not possible. People who are not in a study are usually treated with radiation therapy with weekly FDA-approved chemotherapy. Sometimes, combinations of these are used. These treatments can reduce symptoms and may stop the tumor from growing for several months or more. This study has two study groups.
Group 1 will get the usual cisplatin chemotherapy and radiation therapy used for this type of cancer.
Group 2 will get the usual cisplatin chemotherapy and radiation therapy used for this type of cancer plus an investigational study drug called triapine three times per week. The purpose of this study is to compare any good or bad effects of adding triapine to the usual cisplatin chemotherapy and radiation therapy, compared to using cisplatin chemotherapy and radiation therapy alone. The addition of triapine to the usual chemotherapy and radiation therapy could shrink the tumor and increase the length of time till the cancer returns, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
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Principle Investigator: Catherine Kim, M.D.
Contacts for Participation in Clinical Trials:
Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
Karen Goldsmith, BSN, RN
Maria Jenkins, CCRP
Clinical Research Coordinator