Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
- Conditions
- Sarcoma
- Registration Number
- NCT00874874
- Lead Sponsor
- Centre Oscar Lambret
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of non-progression at 9 months by RECIST criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Oscar Lambret
🇫🇷Lille, France