Evaluation of the oral uracil loading test as a sensitive, simple and cheap method to detect DPD deficiency. - Dutch DPD-uracil study

• Conditions: Extreme toxicity during of after chemotherapy with a 5-fluorouracil of capecitabine containing regimen for colorectal, breast or head and neck cancer.

• Registration Number: EUCTR2006-002861-37-NL
• Lead Sponsor: Ziekenhuisapotheek Meppel-Hoogeveen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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. < 5 nmol/mg/hour

Control 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.
·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

·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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified