NCT00003156

Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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 topotecan in treating patients with recurrent or refractory cancer of the uterus.

Detailed description

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 years.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	topotecan hydrochloride

Timeline

• Start date: 1998-06-01
• Primary completion: 2005-10-01
• First posted: 2004-04-07
• Last updated: 2013-04-11

Locations

46 sites across 2 countries: United States, Canada