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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
OnDose is a commercially available assay to measure concentration of 5-FU exposure.
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
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Birmingham, Alabama, United States
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Corona, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Modesto, California, United States
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Rancho Cucamonga, California, United States
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Riverside, California, United States
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Santa Rosa, California, United States
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Washington D.C., District of Columbia, United States
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Merritt Island, Florida, United States
...and 48 more locations