Cancer (Advanced Stage) Clinical Trial
Official title:
The Optimisation of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer
The purpose of this study is:
1. To determine the proportion of Asian patients achieving a target area under the curve
(AUC) of 20-24 mg.h/L using a pharmacokinetically guided 5-fluorouracil (5-FU) dose
2. To determine the safety and tolerability of dose adjusted 5-FU
3. To correlate 5-FU pharmacokinetics with gene variants associated with the 5-FU pathway
and with clinical outcomes
Based on Western data, levels of 5-FU are highly variable when doses are based on BSA. A
relationship between systemic plasma levels of 5-FU and treatment toxicity and efficacy
exists. Whilst pharmacokinetically-guided dose management has been shown to improve 5-FU
efficacy and tolerance, there is currently no data in Asian patients using this approach.
Using pharmacokinetically guided 5-FU-dose adjustment, the investigators hypothesize the
proportion of Asian patients achieving a target AUC of 20-24 mg.h/L is similar to that of
Caucasians.
METHODS:
This is an open, non-randomised single center Phase II study evaluating dose adjusted 5-FU
in patients receiving de Gramont, FOLFIRI or mFOLFOX-6 schedules.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment