NCT00637091已完成2 期
A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.
详细描述
Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
- •Estimated life expectancy of more than 3 months
- •ECOG performance status of 0 to 1 at study entry
- •Adequate bone marrow function
- •Adequate liver function
- •Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
- •Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
- •Informed Consent
排除标准
- •Central nervous system (CNS) metastases or prior radiation for CNS metastases.
- •Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
- •Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
- •Evidence of gastrointestinal bleeding
- •Exposure to Cetuximab
- •Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
- •KRAS mutant Status
- •Patients with serious toxicity to previous irinotecan-based chemotherapy
- •Other serious illness or medical conditions
研究组 & 干预措施
EGFR expression
Experimental
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
干预措施: Cetuximab, irinotecan (Drug)
结局指标
主要结局
Response rate
时间窗: 8 week
次要结局
- Progression free survival, overall survival(every 8 weeks)
研究者
Tae Won Kim
Professor
Asan Medical Center
研究点 (1)
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