Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
Phase 4
Terminated
- Conditions
- Colorectal Cancer, Metastatic
- Interventions
- Other: Standard of careOther: Pharmacokinetic 5-FU dose adjustment using OnDose® assay
- Registration Number
- NCT01468623
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Body Surface Area (BSA) Standard of care 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® Pharmacokinetic 5-FU dose adjustment using OnDose® assay 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.
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) 6 months
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 30 months