NCT00433927

5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC)

Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (estimated)
• Sponsor: PD Dr. med. Volker Heinemann · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are median progression free survival, median overall survival, safety, and secondary resection rate.

Conditions

• Neoplasm Metastasis
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	5-FU	5-FU 400 mg/m² Bolus day 1 5-FU 2400 mg/m² iv over 46 h day 1-2
DRUG	folinic acid	Folinsäure (racemisch) 400 mg/m² iv, 120 min d 1
DRUG	irinotecan	Irinotecan 180 mg/m² iv, 30 - 90 min day 1
DRUG	cetuximab	Cetuximab initial 400mg/m² as 120 min infusion, than 250 mg/m² iv as 60 min infusion d 1 + 8
DRUG	bevacizumab	Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1

Timeline

• Start date: 2007-01-01
• Primary completion: 2014-04-01
• Completion: 2016-12-01
• First posted: 2007-02-12
• Last updated: 2014-03-14

Locations

1 site across 1 country: Germany