Overview

The Optimization of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer

Status:
Unknown status

Trial end date:
2017-06-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 2

Details

Lead Sponsor:

National University Hospital, Singapore

Treatments:

Fluorouracil