Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer; Quality of Life
Intervention: amifostine trihydrate (Drug); quality-of-life assessment (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Robert H. Lurie Cancer Center Official(s) and/or principal investigator(s):
David A. Fishman, MD, Study Chair, Affiliation: Robert H. Lurie Cancer Center
Summary
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.
Clinical Details
Official title: Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial
Study design: Supportive Care, Randomized
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1999
Last updated: May 23, 2008
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