NCT00003054

Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Evaluation of Paclitaxel (Taxol) 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: 120 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 paclitaxel in treating patients with recurrent or persistent cancer of the uterus.

Detailed description

OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority. II. Determine the nature and degree of toxic effects of paclitaxel in this group of patients. OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours. Patients in complete remission, partial remission, or stable disease undergo at least 3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects prohibit further treatment. All patients are followed until death. PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over 2.5 years.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	paclitaxel

Timeline

• Start date: 1997-08-01
• Primary completion: 2002-07-01
• First posted: 2003-06-25
• Last updated: 2018-04-12

Locations

65 sites across 2 countries: United States, Canada