NCT00138060已完成4 期
Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile
Institut de Recherche Clinique sur les Cancers et le Sang11 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 11
- 主要终点
- tumor response rate
研究概览
简要总结
This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.
The results of this identification determine the chemotherapy type: high-dose irinotecan or not.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice
- •Ages between 18 and 85 years
- •Histologically confirmed colorectal cancer
- •No treatment for metastatic disease
- •No irinotecan previously administered
- •World Health Organization (WHO) performance status < 3
- •Laboratory values :
- •neutrophils > 1.5 x 10^9/L;
- •platelet count > 100 x 10^9/L;
- •serum creatinine < 130µmol/L;
- •serum bilirubin < 2 x upper limit of normal (ULN);
- •ASAT and ALAT < 2.5 x ULN;
- •alkaline phosphatase < 5 x ULN.
- •At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
排除标准
- •History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.
- •Other concomitant anticancer therapy.
- •Pregnant or lactating women.
- •Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- •Symptomatic cerebral or leptospiral metastasis.
- •Intestinal obstruction.
- •Uncontrolled seizures (diabetes, severe infection).
- •Clinically significant cardiac disease.
- •Central nervous system disorders or severe psychiatric disability.
- •Participation in any investigational study within 4 weeks.
结局指标
主要结局
tumor response rate
时间窗: during the treatment
次要结局
- toxicity(during the treatment)
- pharmacokinetics(during the first administration)
研究者
研究点 (11)
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