PHARMACOGENOMIC AND PHARMACOKINETIC SAFETY AND COST-SAVING ANALYSIS IN PATIENTS TREATED WITH FLUOROPYRIMIDINES

Phase 4

• Conditions: mammacarcinoma; DPD-deficiency; metabolism disorder; 10017990; 10037546

• Registration Number: NL-OMON33759
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

- Patient is considered for treatment with capecitabine or 5-FU
- Age 18 years or older
- Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis
- Life expectancy more than 2 months allowing adequate follow up of toxicity evalution and antitumor activity
- Minimal acceptable safety laboratory values
- WHO performance status of 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 in the history that are not suitable for adequate follow up.
- Women who are pregnant, breast feeding or women of childbearing potential who refuse to use a reliable contraceptive method throughout the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter is safety of the treatment of DPYD*2A mutant patients<br /><br>with capecitabine or 5-FU. Toxicity outcome will be monitored according to<br /><br>NCI-CTC. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are:<br /><br>- costs, to determine whether this strategy is cost-saving, which will be<br /><br>assessed by an incremental cost-effectiveness analysis.<br /><br>- to assess an individual treatment algorithm for DPYD*2A mutant patients for<br /><br>capecitabine and 5-FU.<br /><br>- to determine the pharmacokinetic parameters of capecitabine and 5-FU in<br /><br>DPYD*2A mutant patients.<br /><br>- to perform a DPD-activity measurement in patients with the DPYD*2A muation<br /><br>- assessment of the toxicity in wild type patients for DPYD*2A, who have been<br /><br>prospectively screened prior to start of therapy and did actually receive a<br /><br>treatment with fluoropyrimidine drugs, by investigation of the patient files<br /><br>- statusonderzoek naar toxiciteit in wild type patienten voor DPYD*2A, die in<br /><br>het kader van deze studie voorafgaand de therapie gegenotypeerd zijn en<br /><br>daadwerkelijk zijn gestart met een fluoropyrimidinebehandeling. </p><br>