Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal Cancer

Sponsor
Dutch Colorectal Cancer Group
Study ID
NCT00208546
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a study to assess the efficacy and safety of the addition of cetuximab to the combined regimen of capecitabine, oxaliplatin and bevacizumab in patients with previously untreated advanced colorectal carcinoma. It is an open, comparative study, comparing the effects of capecitabine, oxaliplatin and bevacizumab to those of the same regimen plus cetuximab. Seven hundred fifty patients will be included. Treatment will continue until disease progression or serious toxicity and follow up will continue until death. It is anticipated that the addition of cetuximab will lead to an increase in progression free survival.

Key Dates

First listed
Sep 21, 2005
Start date
Jun 30, 2005
Status verified
Feb 2012
Primary completion
Jul 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
750 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1Capecitabine + bevacizumab + oxaliplatin + cetuximab
  • Active Comparator: 21Capecitabine + bevacizumab + oxaliplatin

Primary Outcome Measure

progression free survival [ Time Frame: study duration ]

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