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Protocol No. NRGGY006

Principal Investigator Bradley, Kristin

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title 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, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Objective 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 your 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.

Treatment You will receive the cisplatin chemotherapy and radiation therapy or triapine given with cisplatin chemotherapy and radiation therapy for up to eight weeks.

Description A computer will by chance assign you to treatment groups in the study. This is called randomization. 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. Triapine will need to be given through a tube inserted into a vein near your arm (IV) that allows the drug to be given directly into the vein each time you receive the drug.

Key Eligibility
  • New, untreated histologic diagnosis of state IB2, II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina for which cervical treatment is not possible
  • Uncontrolled diabetes mellitus not allowed
  • Known brain metastases not allowed
  • Known HIV syndrome not allowed

Applicable Disease Sites Cervix; Vagina

Therapies Involved Cytotoxic Chemotherapy; Other; Radiotherapy

Drugs Involved cis-diamminedichloroplatinum (cisplatin); cisplatin; platinol (cisplatin); platinum (cisplatin); triapine

Status Open

Participating Institutions UW Hospital and Clinics