RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in treating
patients who have ovarian epithelial cancer and who are receiving chemotherapy.
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
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.
DISEASE CHARACTERISTICS: Histologically confirmed, surgically staged ovarian epithelial
cancer Planned treatment with paclitaxel/carboplatinum chemotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 3 mg/dL SGOT/SGPT no greater than 2.5
times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No
prior radiotherapy Surgery: See Disease Characteristics Other: At least 24 hours since