Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
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.
|Ovarian Cancer Quality of Life||Drug: amifostine trihydrate Procedure: quality-of-life assessment||Phase 3|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial|
|Study Start Date:||October 1999|
|Study Completion Date:||January 2003|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004166
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||David A. Fishman, MD||Robert H. Lurie Cancer Center|