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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Enrollment
96
Centre Oscar Lambret
Lille, France
RECRUITINGRate of non-progression at 9 months by RECIST criteria
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