Conditions: Metastatic Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 247
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle arm 2: (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU

Interventions: intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Leucovorin intervention 4: Fluorouracil intervention 5: Cetuximab
Intervention descriptions: intervention 1: 5 mg/kg over 30 minutes on Days 1 and 15 intervention 2: 85 mg/m2 on Days 1 and 15 intervention 3: 400 mg/m2 on Days 1 and 15 intervention 4: 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) intervention 5: 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

Protocol document: