A combination of pre-screening for DPD deficiency by genotyping/phenotyping methods and pharmacokinetics-guided dosing of 5-FU for precision treatment to prevent severe toxicity in gastrointestinal cancer patients

Isala0 个研究点目标入组 65 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•age 18 years and older
•histological proof of gastro-intestinal cancer
•patient is considered for treatment with capecitabine or 5-FU
•acceptable safety laboratory values
•ECOG performance status 0-2
•able and willing to give written informed consent
•able and willing to undergo blood sampling for DPYD genotyping, DPD phenotyping and pharmacokinetic analysis

•prior chemotherapy with fluoropyrimidines
•symptomatic or uncontrolled central nervous system metastases
•patient who cannot submit itself to the formal follow-up for psychological, social, family or geographical reasons
•women who are pregnant or breast-feeding
•women not consenting to use adequate contraceptive precautions during the study
•significant serious pathology or any instable medical condition (cardiac pathology uncontrolled, myocardial infarction within 6 months before enrolment, systemic active uncontrolled infection, cirrhosis (Child-Pugh score C), renal failure (GFR < 20 ml/min))
•any investigational agent within 4 weeks before enrolment
•cimetidine or sorivudine use (due to drug-drug interactions with 5-fluorouracil and capecitabine)

发起方