NCT00003316

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• 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 gemcitabine in treating patients with recurrent or refractory cancer of the uterus.

Detailed description

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1998-08-01
• Primary completion: 2004-04-01
• First posted: 2004-04-09
• Last updated: 2013-04-11

Locations

40 sites across 2 countries: United States, Canada