NCT00362102已完成2 期
A Multi-center, Open Label, Non-randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-detectable Metastatic Colorectal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Response according to the RECIST criteria accessed every 6 weeks
研究概览
简要总结
To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must have surgically unresectable metastatic colorectal carcinoma.
- •The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy
- •ECOG PS 0-2
排除标准
- •Subjects with symptomatic cerebral metastasis
结局指标
主要结局
Response according to the RECIST criteria accessed every 6 weeks
次要结局
- Time to progression, duration of achieved response, and the disease control rate will be accessed in all patients who received Cetuximab. The worst toxicity grades per patients will be tabulated for adverse events and laboratory measurements.
研究者
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