Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6 (PROFUSE)
|ClinicalTrials.gov Identifier: NCT01468623|
Recruitment Status : Terminated (Study terminated due to slow enrollment.)
First Posted : November 9, 2011
Last Update Posted : January 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer, Metastatic||Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay Other: Standard of care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
Patients will receive FOLFOX6 with or without bevacizumab (Avastin). Patients' 5-FU dose will be optimized by measuring the Area Under the Curve (AUC) of 5-FU by the commercially available OnDose® assay and their dose for subsequent cycles adjusted following a pre-established dose adjustment algorithm.
Other: Pharmacokinetic 5-FU dose adjustment using OnDose® assay
OnDose is a commercially available assay to measure concentration of 5-FU exposure.
Other Name: OnDose®
Active Comparator: Body Surface Area (BSA)
Patients will receive FOLFOX6 with or without bevacizumab (Avastin). Patients will receive 5-FU based on traditional BSA calculation and their dose adjusted based on standard clinical practice. OnDose® AUC measurements will be performed for this arm but will not be used for dose adjustment.
Other: Standard of care
Patients' dose of 5-FU will be based on Body Surface Area (BSA).
- Overall response rate (ORR) [ Time Frame: 6 months ]
- Progression-free survival (PFS) [ Time Frame: 30 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468623
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|Study Director:||Abebe Haregewoin, MD, PhD||Myriad Genetic Laboratories, Inc.|