NCT00479752

Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer

A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.

Detailed description

This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging. Following permanent treatment cessation, patients will be followed-up for survival.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFOX4 (Oxaliplatin), Cetuximab	Arm A FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 600 mg/m²,over 22 hours, every 2 weeks Cetuximab is administered to arm A of the study as an infusion with initial dose 400 mg/m² in week 1 followed by weekly doses of 250 mg/m². Arm B FOLFOX4: * Oxaliplatin 85 mg/m² d1 * Leucovorin 200 mg/m² d1+d2, followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 600 mg/m², over 22 hours, every 2 weeks Cetuximab is administered to arm B of the study as infusions of 500 mg/m² every two weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-06-01
• Completion: 2015-11-01
• First posted: 2007-05-28
• Last updated: 2016-02-18

Locations

24 sites across 13 countries: Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Greece, Hungary, Israel, Latvia, Romania, Serbia, Slovakia, Slovenia