Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose of Temsirolimus and Vinorelbine
研究概览
简要总结
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or metastatic solid tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the maximal tolerated dose (MTD) for the combination of temsirolimus and vinorelbine in advanced solid tumors.
II. To obtain preliminary information regarding the activity of this combination.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of this combination.
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
Arm I
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: temsirolimus (Drug)
Arm I
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: vinorelbine ditartrate (Drug)
结局指标
主要结局
To determine the maximum tolerated dose of Temsirolimus and Vinorelbine
时间窗: 1 month up to 18 months
To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 2 months up to 18 months
次要结局
- Progression-free and overall survival(Up to 18 months)
- To evaluate the safety and tolerability of Temsirolimus and Vinorelbine(4 weeks up to 36 weeks)