Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00208546|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : February 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: 21Capecitabine + bevacizumab + oxaliplatin Drug: 1Capecitabine + oxaliplatin + bevacizumab + cetuximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cetuximab Added to Capecitabine, Oxaliplatin and Bevacizumab in Patients With Previously Untreated Advanced Colorectal Carcinoma, a Randomised Phase III Study|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: 1Capecitabine + bevacizumab + oxaliplatin + cetuximab||
Drug: 1Capecitabine + oxaliplatin + bevacizumab + cetuximab
3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1, Ce 250 mg/m2 i.v. day 1, 8, 15 (day 1 cycle 1: 400 mg/m2).
|Active Comparator: 21Capecitabine + bevacizumab + oxaliplatin||
Drug: 21Capecitabine + bevacizumab + oxaliplatin
3-weekly cycles: Ca 1000 mg/m2 orally day 1-14, O 130 mg/m2 i.v. day 1 (6 cycles), B 7,5 mg/kg i.v. day 1.
- progression free survival [ Time Frame: study duration ]
- toxicity [ Time Frame: study duration ]
- tumour response (complete response [CR], partial response [PR] or stable disease [SD]) [ Time Frame: study duration ]
- response duration [ Time Frame: study duration ]
- overall survival [ Time Frame: study duration ]
- quality of life [ Time Frame: study duration ]
- translational research [ Time Frame: study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208546
|University Medical Center Nijmegen|
|Nijmegen, Gelderland, Netherlands|
|Principal Investigator:||C JA Punt, MD PhD||University Medical Centre Nijmegen|