Temozolomide Combined With Bevacizumab in Metastatic Melanoma. A Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Clinical benefit number of patients with complete response [CR], partial response [PR], or stable disease) according to RECIST criteria
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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of temozolomide in combination with bevacizumab in patients with unresectable stage IV melanoma.
Secondary
- To evaluate the safety and tolerability of this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
研究组 & 干预措施
Combination Therapy Temozolomide & Bevacizumab
Combination therapy
- Temozolomide 150 mg/m2 p.o., days 1-7, repeated every 14 days
- Bevacizumab 10 mg/kg i.v., day 1, repeated every 14 days
干预措施: bevacizumab (Biological)
Combination Therapy Temozolomide & Bevacizumab
Combination therapy
- Temozolomide 150 mg/m2 p.o., days 1-7, repeated every 14 days
- Bevacizumab 10 mg/kg i.v., day 1, repeated every 14 days
干预措施: temozolomide (Drug)
结局指标
主要结局
Clinical benefit number of patients with complete response [CR], partial response [PR], or stable disease) according to RECIST criteria
时间窗: at 12 weeks
次要结局
- Best overall response (CR, PR) according to RECIST criteria(from trial treatment start until PD)
- Duration of response(time from disease stabilisation until PD)
- Progression free survival(time from trial registration until disease progression or death)
- Overall survival(time from trial registration until death)
- Adverse events(time from start trial treatment until 30 days after treatment stop. Adverse events will be assessed according to NCI CTCAE v3.0.)