NCT00943137

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer (Advanced Stage)

Interventions

Type	Name	Description
DRUG	5-Fluorouracil	Chemotherapy will be one of the following: 1. de Gramont: folinic acid 400mg/m2 day 1, 5-FU 400 mg/m2 bolus on day 1 followed by 46 hour continuous infusion of 5-FU 2400mg/m2. 2. FOLFIRI: Irinotecan 180mg/m2 on day 1, folinic acid 400mg/m2 day 1, 5-FU 400 mg/m2 bolus on day 1 followed by 46 hour continuous infusion of 5-FU 2400mg/m2. 3. Modified FOLFOX-6: Oxaliplatin 85mg/m2 on day 1, folinic acid 400mg/m2 day 1, 5-FU 400 mg/m2 bolus on day 1 followed by 46 hour continuous infusion of 5-FU 2400mg/m2.

Timeline

• Start date: 2009-06-01
• Primary completion: 2016-06-01
• Completion: 2017-06-01
• First posted: 2009-07-22
• Last updated: 2015-06-19

Locations

1 site across 1 country: Singapore