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A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity
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: Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer.
OBJECTIVES: I. Determine the efficacy of amifostine in reducing significant peripheral neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer treated with cisplatin and paclitaxel. II. Determine the proportion of patients on this regimen who experience significant peripheral neuropathy 3 months after completing chemotherapy. III. Assess the overall toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, and cisplatin IV over 90 minutes. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Neurotoxicity is assessed and vibration perception threshold testing is performed prior to each course of chemotherapy and at 3 months following the last treatment. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36 months.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
Chao Family Comprehensive Cancer Center
Orange, California, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States
Start Date
December 1, 1998
Primary Completion Date
January 1, 2004
Last Updated
April 11, 2013
amifostine trihydrate
DRUG
cisplatin
DRUG
paclitaxel
DRUG
Lead Sponsor
Gynecologic Oncology Group
Collaborators
NCT05489211
NCT04657068
Data Source & Attribution
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