NCT01963182已完成2 期
Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
Centre Jean Perrin3 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan
研究概览
简要总结
This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer histologically or cytologically proven
- •Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab
- •Age> 18 years
- •Presence of at least one measurable target by RECIST
- •Life expectancy> 3 months
- •Satisfactory biological functions (renal, hepatic and hematologic)
- •Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the Act of August 9, 2004
- •Patient has signed, after informing the informed consent form
排除标准
- •Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing
- •Patient with another pathology deemed incompatible with the entry in the protocol
- •Prior treatment in metastatic
- •Patients taking antiepileptic
- •Allergic reaction or intolerance to irinotecan
- •Heart failure , kidney , bone marrow , liver or respiratory
- •Higher bilirubin 1.5 times the upper limit of normal
- •Significant psychiatric or neurological abnormality
- •Infectious syndrome requiring treatment with antibiotics or antiviral long-term
- •Patients with chronic inflammatory bowel disease and / or bowel obstruction
- •Contraindication Association St. John's wort and yellow fever vaccine
- •Against Heart indication 5-FU
- •Concurrent treatment with a drug test , participation in a clinical trial within <30 days
- •Patient refused to sign the consent
研究组 & 干预措施
irinotecan dose based on genetic polymorphism of UGT1A1
Experimental
干预措施: Irinotecan (Drug)
结局指标
主要结局
severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan
时间窗: during the treatment (an expected average of 7 months)
次要结局
- evaluation of treatment efficacy (progression-free survival, duration of response)(to progression (1 year))
- Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab(during the first 24 hours of the first cure)
研究者
研究点 (3)
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