Trial Information

Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial

OBJECTIVES: I. Determine if patients with ovarian epithelial cancer receiving chemotherapy
have significantly fewer neurologic events when treated with amifostine. II. Compare
amifostine vs no chemoprotection in terms of overall incidence of neuropathy, incidence of
neutropenia, infection, and other myelosuppressive events (e.g., leukopenia, anemia, and
thrombocytopenia), length of hospital stay due to infections, and quality of life in this
patient population.

OUTLINE: This is a randomized, parallel, controlled, double blind study. Patients are
randomized to one of two treatment arms. Arm I: Patients receive amifostine IV over 10
minutes, 30 minutes prior to chemotherapy. Arm II: Patients receive a placebo IV over 10
minutes, 30 minutes prior to chemotherapy. Treatment repeats every 3 weeks for 8 courses in
the absence of disease progression or unacceptable toxicity. Quality of life is assessed
prior to courses 1, 4, and 8, and then every 3 months for 1 year. Patients are followed
monthly for 6 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.