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Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus

Phase 2
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Trial Information

Evaluation of Topotecan in the Treatment of Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus

OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or
refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the
nature and degree of toxic effects of topotecan in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats
every 3 weeks for a minimum of 1 course in the absence of disease progression or
unacceptable toxicity. Patients with complete response, partial response, or stable disease
continue treatment for at least three courses. Patients are followed every 4 months for 2
years, every 6 months for 3 years, and then periodically thereafter until death.

PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory carcinosarcoma
(mixed mesodermal tumors) of the uterus Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: GOG 0-2 Life Expectancy:
Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte
count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times
ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 20
mL/min Other: No invasive malignancies within the past 5 years except nonmelanomatous skin
cancer No significant infection

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 topotecan
or camptothecin therapy No more than 1 prior chemotherapy regimen (either single or
combination chemotherapy) Endocrine therapy: At least 3 weeks since prior endocrine
therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery:
Prior surgery allowed and recovered

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • Carcinosarcoma
  • Uterine Neoplasms
  • Sarcoma



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