Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial
amifostine trihydrate
+ quality-of-life assessment
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Supportive Care Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 prior antihypertensives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps