NCT00063141已完成3 期
Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,302
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
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 documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.
- •Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
- •Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the first-line treatment of metastatic disease.
排除标准
- •A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy
- •Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
- •Known or documented brain metastases
研究组 & 干预措施
Arm A
Experimental
干预措施: cetuximab (Drug)
Arm A
Experimental
干预措施: Irinotecan (Drug)
Arm B
Active Comparator
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival
时间窗: Every 3 months after subject off-treatment
次要结局
- Progression Free Survival(Q6 Weeks)
- Response(Q6 Weeks)
- Duration of Response(Q6 Weeks)
- Time to Response(Q6 Weeks)
- Disease Control Rate(Q6 Weeks)
- Safety(Q3 Weeks)
- Quality of Life(Q6 Weeks)
- Health Economics(Q3 Weeks)
研究者
研究点 (1)
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