First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer

Sponsor
Azienda Ospedaliero, Universitaria Pisana
Study ID
NCT01437618
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • FOLFOXIRI plus bevacizumab — DRUG
    * BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by * IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by * OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with * l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by * 5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks

Study Details

The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients

Key Dates

First listed
Sep 21, 2011
Start date
Jun 30, 2009
Status verified
Sep 2011
Completion
May 31, 2011

Study Design

Enrollment
15 participants (actual)

Arms

  • Arm: BRAF mutant mCRC

Primary Outcome Measure

Progression-Free Survival [ Time Frame: About 24-30 months (From treatment initiation to evidence of progression or death from any cause) ]

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