NCT00286130

Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety. The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

Detailed description

The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC. EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively. Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan
DRUG	FOLFOX 6	FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:
DRUG	FOLFIRI	FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Timeline

• Start date: 2005-07-01
• Completion: 2007-10-01
• First posted: 2006-02-03
• Last updated: 2012-05-01

Locations

27 sites across 13 countries: Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czechia, Hungary, Israel, Portugal, Romania, Slovakia, Slovenia, Turkey (Türkiye)