Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6 (PROFUSE)
Colorectal Cancer, Metastatic
About this trial
This is an interventional treatment trial for Colorectal Cancer, Metastatic focused on measuring Colorectal cancer, metastatic, FOLFOX6, 5-FU, First line, bevacizumab
Eligibility Criteria
Selection Criteria:
- Patients with histologically confirmed metastatic colorectal cancer
- No prior chemotherapy for the treatment of metastatic colorectal cancer
- At least one measurable lesion by CT or MRI of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan)
- ECOG Performance Status (ECOG-PS) status ≤ 2
- At least 18 years of age
- Life expectancy > 6 months
- Must be able and willing to give written informed consent
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods (abstinence, condom).
- ANC count greater than or equal to 1,500/ mm³
- Platelets greater than or equal to 100,000/ mm³
- Serum creatinine less than or equal to 2x upper limit of normal (normal range (male): 97-137 mL/min; (female): 88-128 mL/min)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3x the upper limit of normal (≤ 5.0 x ULN is acceptable if liver has tumor involvement) (ALT normal range: < 41 iu/L (male), < 31 iu/L (female); AST normal range: < 37 iu/L (male), < 31 iu/L (female)).
- Prothrombin Time (PT), activated partial thromboplastin time (aPTT) and INR ≤ 1.5 x ULN (INR normal range: 0.8-1.2) or in the therapeutic range if on anticoagulation.
- Hemoglobin greater than or equal to 9 gm/dl (may be corrected by transfusion prior to 5-FU treatment with investigator approval).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
OnDose®
Body Surface Area (BSA)
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.