NCT00731276已完成1 期
Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
National Cancer Centre, Singapore1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.
详细描述
OBJECTIVES:
Primary
- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors.
Secondary
- To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites SN-38 and SN-38G.
- To evaluate time to tumor response, response duration, and time to progression in these patients.
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
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Four Regimens
Other
The study has four type of regimens, and dosing of irinotecan depends on genotype of patient.
Four Regimens are:
- Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly
- Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
- Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
- Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly
干预措施: irinotecan hydrochloride (Drug)
Four Regimens
Other
The study has four type of regimens, and dosing of irinotecan depends on genotype of patient.
Four Regimens are:
- Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly
- Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
- Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
- Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly
干预措施: pharmacogenomic studies (Other)
Four Regimens
Other
The study has four type of regimens, and dosing of irinotecan depends on genotype of patient.
Four Regimens are:
- Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly
- Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
- Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
- Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly
干预措施: pharmacological study (Other)
结局指标
主要结局
Dose-limiting toxicity
时间窗: No time frame defined. Trial is still recruiting.
Maximum tolerated dose
时间窗: No time frame defined. Trial is still recruiting.
次要结局
- Pharmacokinetics(No time frame defined. Trial is still recruiting.)
- Time to progression(No time frame defined. Trial is still recruiting.)
- Response duration(No time frame defined. Trial is still recruiting.)
- Time to tumor response(No time frame defined. Trial is still recruiting.)
研究者
研究点 (1)
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