Ovarian Cancer Clinical Trial
Official title:
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.
;
Primary Purpose: Supportive Care
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