Sarcoma Clinical Trial
Official title:
Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients with
recurrent or refractory cancer of the uterus.
OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or
persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II.
Determine the toxicity of gemcitabine in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat
every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with
partial response, complete response, or stable disease receive at least 3 courses of
therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
;
Primary Purpose: Treatment
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