Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Capecitabine; Fluorouracil

Criteria

Inclusion Criteria:

• Histological proof of cancer

• patient is considered for treatment with capecitabine or 5-FU

• hetero- or homozygous mutant for DPYD*2A

• able and willing to give written informed consent

• able and willing to undergo blood sampling for pharmacokinetic analysis

• life expectancy 3 months or longer

• acceptable safety laboratory values (ANC, platelet count, ASAT, ALAT, creatinine,

• WHO performance status 0-2

• no radio- or chemotherapy within the last 3 weeks prior to study entry

Exclusion Criteria:

• patients with known alcoholism, drug addiction and/or psychotic disorders that are not suitable for adequate follow-up

• women who are pregnant or breast-feeding