NCT00689624

Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer

A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital of Crete · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

Detailed description

The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
DRUG	Leukovorin	Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
DRUG	Oxaliplatin	Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
DRUG	5-FLUOROURACIL	5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3
DRUG	Cetuximab	Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-06-03
• Last updated: 2015-09-28

Locations

1 site across 1 country: Greece