NCT00238121

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sorafenib 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. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib. II. Determine the toxic effects of this drug in these patients. SECONDARY OBJECTIVES: I. Determine progression-free survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to histology (carcinoma vs carcinosarcoma). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

• Recurrent Uterine Sarcoma
• Stage III Uterine Sarcoma
• Stage IV Uterine Sarcoma
• Uterine Carcinosarcoma

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally

Timeline

• Start date: 2005-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2005-10-13
• Last updated: 2015-11-20
• Results posted: 2014-06-10

Locations

7 sites across 2 countries: United States, Canada