The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.
This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be randomized on a 1:1 basis to either treatment Arm. In this trial, we will compare the efficacy, safety, and tolerability of this novel combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB) to the current standard of care, biweekly infusional 5-FU/leucovorin plus oxaliplatin and bevacizumab (Bev-FOLFOX). For practical purposes, this study will be a head to head comparison of oxaliplatin versus cetuximab, since the other components of both regimens will be the same.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
247
5 mg/kg over 30 minutes on Days 1 and 15
85 mg/m2 on Days 1 and 15
400 mg/m2 on Days 1 and 15
Progression-Free Survival (PFS)
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring). Kaplan-Meier median PFS time and PFS rate (at 12 months)
Time frame: 12 months
Progression-free Survival (PFS) Rate at 1 Year.
From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).
Time frame: 12 months
Overall Survival (OS)
From randomization to death (event); or last follow-up date if alive (censoring). Kaplan-Meier OS median time.
Time frame: up to 4 years
Objective Response Rate
Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all "per-protocol population" patients.
Time frame: 12 months
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400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period)
400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour
Brimingham Hematology and Oncology
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Cancer Care Associates of Fresno Medical Group, Inc (aka California Cancer Care)
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Monterey Bay Oncology
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Rocky Mountain Cancer Center-Midtown
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Greeley Medical Clinic Oncology Hematology, PC
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Connecticut Oncology & Hematology, LLP
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Integrated Community Oncology Network (ICON) / fka:Florida Oncology Associates
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...and 72 more locations