The Optimization of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer
|ClinicalTrials.gov Identifier: NCT00943137|
Recruitment Status : Unknown
Verified June 2015 by National University Hospital, Singapore.
Recruitment status was: Active, not recruiting
First Posted : July 22, 2009
Last Update Posted : June 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer (Advanced Stage)||Drug: 5-Fluorouracil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Optimisation of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2017|
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:
- AUC of 20-24 mg.h/L [ Time Frame: 28 days - 2 cycles ]If patient achieved target AUC for two consecutive cycles, therapeutic dose monitoring will performed every alternate cycle.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943137
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Thomas Soh, MBBS||National University Hospital, Singapore|