NCT00378911

Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

A Phase II Evaluation of Sunitinib Malate (Sutent®, SU11248, NCI-Supplied Agent , NSC # 736511) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Assess the activity of sunitinib malate, in terms of rate of progression-free survival for ≥ 6 months and objective tumor response, in patients with recurrent or persistent leiomyosarcoma of the uterus who have received 1 or 2 prior cytotoxic therapies. II. Determine the frequency and severity of adverse events. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival. OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Conditions

• Recurrent Uterine Sarcoma
• Uterine Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given orally

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-06-01
• Completion: 2010-01-01
• First posted: 2006-09-21
• Last updated: 2019-07-23

Locations

1 site across 1 country: United States