Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or
persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher
priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group of
patients.

OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3
hours. Patients in complete remission, partial remission, or stable disease undergo at least
3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects
prohibit further treatment. All patients are followed until death.

PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over
2.5 years.

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine
leiomyosarcoma that is refractory to curative therapy or established treatments Measurable
disease required Must have failed local therapeutic measures and must be considered
incurable Not eligible for GOG protocols of higher priority

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal
SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater
than 2.0 mg/dL Cardiovascular: No unstable angina within 6 months OR No myocardial
infarction within 6 months Abnormal cardiac condition (e.g., bundle branch block, heart
block) allowed if stable for 6 months Other: No significant infection No concomitant
malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: At least 3 weeks since prior therapy to malignant tumor Biologic
therapy: Not specified Chemotherapy: Recovery from prior chemotherapy required No more than
1 prior chemotherapy regimen allowed No prior paclitaxel No prior chemotherapy for any
malignancy from which the patient is disease-free for at least 5 years Endocrine therapy:
Not specified Radiotherapy: Recovery from prior radiation therapy required No prior
radiation therapy for any malignancy from which the patient is disease-free for at least 5
years Surgery: Recovery from prior surgery required