Neoplasms

Digestive System Diseases

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Colorectal Neoplasms

Intestinal Neoplasms

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Gastrointestinal Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Fluorouracil

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.

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.

OnDose is a commercially available assay to measure concentration of 5-FU exposure.

Pharmacokinetic 5-FU dose adjustment using OnDose® assay

Patients' dose of 5-FU will be based on Body Surface Area (BSA).

Standard of care

Abebe Haregewoin, MD, PhD

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 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

Myriad Genetic Laboratories, Inc.

Spots Global Cancer Trial Database for colorectal cancer, metastatic