Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Rate of non-progression at 9 months by RECIST criteria
|Study Start Date:||May 2008|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874874
|Centre Oscar Lambret|
|Lille, France, 59020|
|Principal Investigator:||Nicolas Penel, MD||Centre Oscar Lambret|