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Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Phase 2
18 Years
Not Enrolling

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Trial Information

Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma 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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine
leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local
therapeutic measures and considered incurable Measurable disease Not eligible for a higher
priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 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 no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal
Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5
years since any other invasive malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine
No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine
therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks
since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Katherine Y. Look, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • uterine leiomyosarcoma
  • Leiomyosarcoma
  • Uterine Neoplasms
  • Sarcoma



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