Safety, feasibility and cost-effectiveness of genotype-directed individualized dosing of fluoropyrimidines
- Conditions
- Cancer (breast cancercolorectal cancergastric cancer)10027656
- Registration Number
- NL-OMON45080
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1250
1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient*s best interest
2. WHO performance status of 0, 1 or 2
3. Life expectancy of at least 12 weeks
4. Able to swallow and retain oral medication
5. Able and willing to undergo blood sampling for pharmacogenetic and phenotyping analysis;For subgroup only:
6. Able and willing to undergo blood sampling and breath sampling at several time points
7. Able and willing to receive uracil for the test dose assay
8. Able and willing to receive [2-13C] -labeled uracil for the breath test
1. Prior treatment with fluoropyrimidines
2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety
3. Women who are pregnant or breast feeding
4. Both men and women who refuse to use reliable contraceptive methods throughout the study
5. Patients with a homozygous polymorphic genotype or compound heterozygous genotype for DPYD.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint in this study is the incidence of severe treatment-related<br /><br>toxicity (CTC grade 3 to 5) in patients carrying DPYD variants compared to<br /><br>wild type patients. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are: cost-effectiveness, assessment of pharmacokinetics and<br /><br>DPD enzyme activity.</p><br>