NCT00238849Unknown2 期
Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer
Integrated Community Oncology Network3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.
详细描述
This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
- •Measurable disease
- •Good performance status (ECOG 0,1 or 2)
排除标准
- •Previously treated with Oxaliplatin or Navelbine
- •Symptomatic CNS metastases
结局指标
主要结局
Efficacy
次要结局
- Time to progression
- Duration of response
- Survival
- Toxicity profile
研究者
研究点 (3)
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