NCT01468623

Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6

A Prospective, Randomized, Open-label Trial Comparing OnDose® AUC Optimized 5-FU Based Administration Versus Standard Body Surface Area (BSA) Dosing in Metastatic Colorectal Cancer Patients (mCRC) Treated With mFOLFOX6

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Myriad Genetic Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to BSA dosing response.

Conditions

• Colorectal Cancer, Metastatic

Interventions

Type	Name	Description
OTHER	Pharmacokinetic 5-FU dose adjustment using OnDose® assay	OnDose is a commercially available assay to measure concentration of 5-FU exposure.
OTHER	Standard of care	Patients' dose of 5-FU will be based on Body Surface Area (BSA).

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-11-09
• Last updated: 2023-07-19

Locations

58 sites across 1 country: United States