An Open Label Multicenter Phase II Study of Bevacizumab for the Treatment of Angiosarcoma
- Determine the median progression-free survival, in terms of stable disease, of patients
with newly diagnosed or recurrent/refractory angiosarcoma treated with bevacizumab.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate median progression-free survival of patients treated with the study drug, bevacizumab.
During treatment, tumor assessment will be done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment. After Study drug completion, tumor assessment will be assessed by MRI every 3 to 4 months (for 2 years after the last bevacizumab dosage).
After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years
Mark Agulnik, MD
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Rebecca and John Moores UCSD Cancer Center||La Jolla, California 92093-0658|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Fox Chase Cancer Center CCOP Research Base||Philadelphia, Pennsylvania 19140|