Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma
- To evaluate the efficacy of temozolomide in combination with bevacizumab in treating
patients with metastatic uveal melanoma not amenable to curative surgery.
- To determine response rate in these patients.
- To determine duration of response in these patients.
- To determine progression-free survival of these patients.
- To determine overall survival of these patients.
- To determine the safety of treatment with this regimen in these patients.
- To study the CT perfusion imaging for functional imaging of response in these patients.
- To determine the pharmacogenetic influence of constitutional VEGF-A polymorphism on the
efficacy and toxicity of bevacizumab. (ancillary)
OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and 15-21 and bevacizumab
IV over 30-90 minutes on days 8 and 22. Treatment repeats every 28 days for up to 6 courses.
Patients achieving at least stable disease then receive bevacizumab monotherapy IV every 2
weeks as maintenance therapy in the absence of unacceptable toxicity and disease
progression. Patients undergo CT perfusion imaging at baseline, day 28, and at 3 and 6
Blood samples are collected at baseline and then periodically for VEGF-A genetic
After completion of study treatment, patients are followed up at 1 month.
Masking: Open Label, Primary Purpose: Treatment
Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months
Sophie Piperno-Neumann, MD