DPD deficiency
Conditions
Interventions
5-FU dose adaptation according to the IATDMCT guideline.
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the clearance of 5-FU at steady state (Clss) measured in ml/min. Among cancer patients treated with 5-FU, we will compare the variation in clearance between the four common DPYD variant allele carriers and DPYD wild-type carriers. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are the incidence of 5-FU related toxicities, U/DHU ratio, DPD phenotype (EM, IM, and PM), 5-FU doses, dosage adjustment and time to reach target AUC (cycle number). | — |
Countries
Netherlands
Outcome results
None listed