NCT00287963已完成1 期
A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.
Secondary
- Assess the response and stable disease rates and the time to disease progression among treated patients.
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 120 Years（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
Vinorelbine + topotecan
Experimental
干预措施: vinorelbine tartrate (Drug)
Vinorelbine + topotecan
Experimental
干预措施: topotecan hydrochloride (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: Cycle 1 (up to day 21)
次要结局
- Response rate(while on study, at the end of each 3 week cycle)
- stable disease rate(while on study, at the end of each 3 week cycle)
- time to progression(from start of treatment to day of documented progression or death, whichever comes first, up to 36 months)
研究者
研究点 (1)
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