NL-OMON29105
Recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Isala
- Enrollment
- 65
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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