Open-label, Multicenter, Phase II Study Of First-line Biweekly Irinotecan, Oxaliplatin And Infusional 5-FU/LV (FOLFOXIRI) In Combination With Bevacizumab In Patients With Metastatic Colorectal Cancer (FOIB)

NCT01163396 Phase 2 COMPLETED

This is a single-arm, open-label, multicentre phase II study evaluating the safety and efficacy of the combination of the G.O.N.O. FOLFOXIRI regimen with bevacizumab as first-line treatment of metastatic colorectal cancer.

Details

Lead sponsor	Gruppo Oncologico del Nord-Ovest
Phase	Phase 2
Status	COMPLETED
Enrolment	57
Start date	2007-07
Completion	2010-04

Conditions

• Colorectal Cancer Metastatic

Interventions

• Bevacizumab
• Irinotecan
• Oxaliplatin
• 5-fluorouracil/leucovorin

Primary outcomes

• Progression-free survival (PFS) — PFS rate at 10 months from study entry
  PFS was calculated from the day of treatment start to the first observation of disease progression or death from any cause.