NCT00233623撤回2 期
A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 190
- 试验地点
- 13
- 主要终点
- Time to progression (6 months after Last patient in)
研究概览
简要总结
The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed metastatic colorectal cancer
- •Presence of measurable metastases
- •No previous treatment for metastatic cancer
排除标准
- •No presence of Central Nervous System metastases
- •No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
结局指标
主要结局
Time to progression (6 months after Last patient in)
次要结局
- Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)
研究者
研究点 (13)
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