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A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity (NCT00003624)

National Cancer Institute (NCI)
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.
  • Drug: amifostine trihydrate
    • Drug: cisplatin
      • Drug: paclitaxel
        Ages eligible for Study
        Genders eligible for Study
        Accepts Healthy Volunteers
        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.

        8 locations

        United States (8)
        • Chao Family Comprehensive Cancer Center
          Not specified
          Orange, California, United States, 92868
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
          Not specified
          Washington, District of Columbia, United States, 20007
        • Emory University Hospital - Atlanta
          Not specified
          Atlanta, Georgia, United States, 30322
        • University of Chicago Cancer Research Center
          Not specified
          Chicago, Illinois, United States, 60637
        • Indiana University Cancer Center
          Not specified
          Indianapolis, Indiana, United States, 46202-5265
        • Washington University School of Medicine
          Not specified
          Saint Louis, Missouri, United States, 63110
        • Lineberger Comprehensive Cancer Center, UNC
          Not specified
          Chapel Hill, North Carolina, United States, 27599-7295
        • Cleveland Clinic Cancer Center
          Not specified
          Cleveland, Ohio, United States, 44195
        30 November, 1998
        09 April, 2013
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