First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT01163396
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2007
Status verified
Mar 2015
Primary completion
Apr 30, 2009
Completion
Apr 30, 2010

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOXIRI plus bevacizumab
    BEVACIZUMAB 5 mg/Kg i.v. followed by IRINOTECAN 165 mg/sqm i.v. over 1 hr followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hr concomitantly with l-LV 200 mg/sqm over 2 hrs followed by 5FU 3.200 mg/sqm c.i. over 48 hrs starting on day 1. Cycles repeated every 2 weeks

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: PFS rate at 10 months from study entry ]

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