Personalized prediction and regulation of 5-FU exposure
Phase 4
Recruiting
- Conditions
- intestinal cancer10017991
- Registration Number
- NL-OMON54497
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patient undergoing FOLFOX, FOLFIRI or FOLFIRINOX treatment.
2. Patient with age >= 18.
3. Patient is able and willing to give written informed consent.
4. Patient is able and willing to undergo extra blood sampling for 5-FU
analysis.
Exclusion Criteria
1. Patients with known substance abuse, psychotic disorders, and/or other
diseases expected to interfere with study or the patient*s safety.
2. Inability to perform additional blood sampling in patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of the patients that achieve optimal 5-FU exposure within two<br /><br>dose cycles of 5-FU, which is defined by an AUC target of 5-FU between 20 and<br /><br>30 mg h/L or dose limiting toxicity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints of this study are: the minimum amount of blood sample<br /><br>required to safely adjust 5-FU dosing in our routine clinical practice, AUC<br /><br>contribution of 5-FU bolus infusion in PK model versus simple formula (Css x<br /><br>t), frequency of AEs below, within and above target window, intra-individual<br /><br>variation in 5-FU AUC, correlation DPD activity with 5-FU exposure and toxicity<br /><br>and the correlation between AEs and total 5-FU exposure.</p><br>