The Optimization of 5-Fluorouracil Dose by Pharmacokinetic Monitoring in Asian Patients With Advanced Stage Cancer
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|