NCT00301847

Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain

A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain

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

Summary

This phase II trial is studying how well sorafenib works in treating patients with kidney cancer that has spread to the brain. 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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC) metastatic to the brain treated with sorafenib. SECONDARY OBJECTIVES: I. Determine the toxicity of sorafenib in patients with RCC metastatic to the brain. II. Determine whether the effect of sorafenib on RCC metastatic to the brain is similar to its effect on non-brain metastatic sites. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Conditions

• Kidney Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-06-01
• First posted: 2006-03-13
• Last updated: 2013-02-11

Locations

12 sites across 1 country: United States