NCT00005643

Chemotherapy in Treating Patients With Sarcoma of the Uterus

Evaluation of Doxil in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 21 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 liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.

Detailed description

OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.

Conditions

• Endometrial Cancer
• Sarcoma

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin hydrochloride

Timeline

• Start date: 2000-05-01
• Primary completion: 2005-03-01
• First posted: 2004-04-19
• Last updated: 2013-06-10

Locations

49 sites across 2 countries: United States, Canada