NCT00107432

Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.

A Phase II Study of BAY 43-9006 (NSC #724772) in Patients With Malignant Mesothelioma

• 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 malignant mesothelioma. 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. To determine the response rate (partial response (PR) and complete response (CR)) in patients with malignant mesothelioma treated with BAY 43-9006. SECONDARY OBJECTIVES: I. To determine 3-month failure free survival in patients with malignant mesothelioma treated with BAY 43-9006. II. To describe the median and overall survival of malignant mesothelioma patients treated with BAY 43-9006. III. To describe the toxicity profile of BAY 43-9006 in patients with malignant mesothelioma. IV. To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf gene and correlate these findings with anti-tumor activity of BAY 43-9006. V. To determine whether the amount of expression of phospho-ERK1/2, as determined by immunohistochemistry from pre-treatment tumor specimens, correlates with anti-tumor activity of BAY 43-9006 in patients with mesothelioma. VI. To determine whether baseline levels and changes following BAY 43-9006 treatment in angiogenic cytokines (VEGF and PDGF) correlate with anti-tumor activity of BAY 43-9006. 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 at least every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

Conditions

• Epithelial Mesothelioma
• Recurrent Malignant Mesothelioma
• Sarcomatous Mesothelioma
• Stage IA Malignant Mesothelioma
• Stage IB Malignant Mesothelioma
• Stage II Malignant Mesothelioma
• Stage III Malignant Mesothelioma
• Stage IV Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-06-01
• First posted: 2005-04-06
• Last updated: 2013-06-05

Locations

2 sites across 1 country: United States