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
- Determine the rate of non-progression at 9 months in patients with unresectable,
locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate.
- 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
- 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.
Allocation: Non-Randomized, Primary Purpose: Treatment
Rate of non-progression at 9 months by RECIST criteria
Nicolas Penel, MD
Centre Oscar Lambret