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

NCT00838370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-03-04

No results posted yet for this study

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.

Conditions

  • Neoplasms

Interventions

DRUG

Capecitabine, 5-fluorouracil

Patients to treat with capecitabine/5-FU will be screened prior to start of therapy for DPYD\*2A. Patients heterozygous or homozygous mutant for DPYD\*2A receive dose reductions of capecitabine/5-FU of at least 50% in the first two courses. In case this dose is tolerated well, doses will be increased. In addition, the pharmacokinetics of capecitabine/5-FU and their metabolites will be assessed in these patients.

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Jan HM Schellens, MD, PhD · Netherlands Cancer Institute, Amsterdam, the Netherlands

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838370 on ClinicalTrials.gov