RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic, recurrent, or refractory endometrial cancer.
OBJECTIVES: I. Evaluate the efficacy of paclitaxel and carboplatin with amifostine on progression free survival and overall survival in patients with metastatic or recurrent epithelial endometrial carcinoma not amenable to surgery or radiotherapy. II. Evaluate response (confirmed and unconfirmed partial response and complete response) rate to this regimen in this patient population. III. Assess the nature and degree of toxicity of this regimen in these patients. OUTLINE: Patients receive paclitaxel IV over 3 hours, then amifostine IV over 10 minutes, followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days. Treatment continues for 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 35 to 50 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
740 mg/m2 IV, Day 1, q 28 days X 6 cycles
target AUC=6, IV Day 1, q 28 days X 6 cycles
175 mg/m2, IV, Day 1 q 28 days X 6 cycles
Progression free survival
from date of registration to date of first observation of progressive disease, deathe due to any cause, or early discontinuation of treatment.
Time frame: 6 months
overall survival
From date of registration to date of death due to any cause
Time frame: 6 months
response
Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No disease progression. No new lesions.
Time frame: after 12 and 24 weeks
toxicity
assessment per SWOG toxicity criteria
Time frame: Weekly X 3, q 4 weeks X 6 cycles
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