Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6 (PROFUSE)
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|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 ]
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): NCT01468623
|Study Director:||Abebe Haregewoin, MD, PhD||Myriad Genetic Laboratories, Inc.|