Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving temozolomide together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of temozolomide in combination with bevacizumab in treating patients with metastatic uveal melanoma not amenable to curative surgery.
Secondary
- 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)
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months
次要结局
- Functional imaging of response by CT perfusion imaging
- Response rate
- Progression-free survival
- Duration of response
- Overall survival
- Safety of this regimen in these patients