Sarcoma Clinical Trial
Official title:
An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with
angiosarcoma.
OBJECTIVES:
Primary
- Determine the median progression-free survival, in terms of stable disease, of patients
with newly diagnosed or recurrent/refractory angiosarcoma treated with bevacizumab.
Secondary
- Evaluate the treatment effect of bevacizumab on the objective response rate as assessed
by modified RECIST criteria in patients with angiosarcoma.
- Evaluate the duration of response.
- Assess the treatment effect of bevacizumab on duration of overall survival.
- Explore the objective response by target tumor density changes on CT scan.
- Evaluate the safety and tolerability of bevacizumab in patients with angiosarcoma.
OUTLINE: This is an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 to 4 months for 2 years.
PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.
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