Extreme toxicity during of after chemotherapy with a 5-fluorouracil of capecitabine containing regimen for colorectal, breast or head and neck cancer.
Conditions
Interventions
Product Name: uracil
Product Code: uracil
Pharmaceutical Form: Powder for oral suspension
Sponsors
Ziekenhuisapotheek Meppel-Hoogeveen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Case group ·Age > 18 years ·More than expected toxicity (grade 3-4, see table 2) after treatment with a 5-FU or capecitabine containing regimen, with clinical suspicions for DPD deficiency. All 5-FU or capecitabine containing chemotherapy schedules are allowed. ·Reduced DPD activity, i.e. 18 years ·More than expected toxicity (grade 3-4, see table 2) after treatment with a 5-FU or capecitabine containing regimen, with clinical suspicions for DPD deficiency. All 5-FU or capecitabine containing chemotherapy schedules are allowed. ·Normal DPD activity i.e. > 5 nmol/mg/hour Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Pregnancy ·Breast feeding ·Cimetidine use (due to drug-drug interactions with 5-fluorouracil and capecitabine) ·Renal failure (creatinine clearance less than 20 ml/min, calculated with Cockroft&Gault formula).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to establish the sensitivity and specificity of an oral uracil loading test as a potential screening tool for DPD deficiency.;Secondary Objective: ;Primary end point(s): The sensitivity and specificiy of the uracil loading test, when compared to measurement of DPD activity in blood mononuclear cells as 'gold standard'. | — |
Countries
Netherlands
Outcome results
None listed