The Optimization of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer
The purpose of this study is:
- 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
- To determine the safety and tolerability of dose adjusted 5-FU
- 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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Optimisation of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer|
- AUC of 20-24 mg.h/L [ Time Frame: 28 days - 2 cycles ] [ Designated as safety issue: No ]If patient achieved target AUC for two consecutive cycles, therapeutic dose monitoring will performed every alternate cycle.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: 5-FU dosage adjustments
The dose of continuous infusion 5-FU will be adjusted every cycle until patients reached the therapeutic plasma range (450 to 550 microgram/L).
Chemotherapy will be one of the following:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943137
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Thomas Soh, MBBS||National University Hospital, Singapore|