NCT00874874

Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery

Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: 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. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

Detailed description

OBJECTIVES: Primary * Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate. Secondary * Determine the rate of non-progression at 60, 120, and 180 days. * Determine the median time to progression. * Determine overall survival. * Determine the best response rate. * Determine the clinical and biological factors that predict clinical benefit. * Evaluate tolerability by NCI CTCAE v3.0. * Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis. * Explore the tumor expression of these genes in tissue from a tumor bank. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (cutaneous angiosarcoma \[scalp, breast, or soft tissue\] vs visceral angiosarcoma). All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	sorafenib tosylate

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-05-01
• First posted: 2009-04-03
• Last updated: 2009-12-24

Locations

1 site across 1 country: France