Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- safety
研究概览
简要总结
The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed.
详细描述
Patients exhibiting a genetically determined disorder (DPYD*2A) in the metabolic degradation of the frequently used anticancer agents capecitabine and 5-FU (fluoropyrimidines) are at high risk of development of severe and life-threatening toxicity during standard treatment with these compounds. Treatment and recovery of this fluoropyrimidine-induced severe toxicity often requires prolonged periods of hospitalization.
Screening for DPYD*2A in patients to treat with fluoropyrimidine drugs with subsequent dose adjustments in mutant individuals prior to start of therapy will possibly reduce the number of severe toxicity events. Furthermore, by reducing the frequency and/or duration of hospitalization, substantial medical costs can be saved, making this a cost-effective strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Histological proof of cancer
- •patient is considered for treatment with capecitabine or 5-FU
- •hetero- or homozygous mutant for DPYD*2A
- •able and willing to give written informed consent
- •able and willing to undergo blood sampling for pharmacokinetic analysis
- •life expectancy 3 months or longer
- •acceptable safety laboratory values (ANC, platelet count, ASAT, ALAT, creatinine,
- •WHO performance status 0-2
- •no radio- or chemotherapy within the last 3 weeks prior to study entry
排除标准
- •patients with known alcoholism, drug addiction and/or psychotic disorders that are not suitable for adequate follow-up
- •women who are pregnant or breast-feeding
研究组 & 干预措施
DPYD*2A
Patients are screened for a DPD-deficiency. Patients with a DPYD*2A mutation are eligible for intervention with capecitabine/5-FU .
干预措施: Capecitabine, 5-fluorouracil (Drug)
结局指标
主要结局
safety
时间窗: during fluoropyrimidine treatment of the patient
次要结局
- cost-effectiveness(during fluoropyrimidine treatment of the patient)