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Sponsors and Collaborators: |
Dutch Colorectal Cancer Group Koningin Wilhelmina Fonds (Dutch Cancer Fund) Sanofi-Aventis Hoffmann-La Roche Immunicon |
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Information provided by: | Dutch Colorectal Cancer Group |
ClinicalTrials.gov Identifier: | NCT00208546 |
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 | Intervention | Phase |
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Colorectal Cancer |
Drug: 21Capecitabine + bevacizumab + oxaliplatin Drug: 1Capecitabine + oxaliplatin + bevacizumab + cetuximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Cetuximab Added to Capecitabine, Oxaliplatin and Bevacizumab in Patients With Previously Untreated Advanced Colorectal Carcinoma, a Randomised Phase III Study |
Enrollment: | 750 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1Capecitabine + bevacizumab + oxaliplatin + cetuximab: Experimental |
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).
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21Capecitabine + bevacizumab + oxaliplatin: Active Comparator |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histology and Staging Disease
General Conditions
Exclusion Criteria:
Netherlands, Gelderland | |
University Medical Center Nijmegen | |
Nijmegen, Gelderland, Netherlands |
Principal Investigator: | C JA Punt, MD PhD | University Medical Centre Nijmegen |
Responsible Party: | Dutch Colorectal Cancer Group ( Prof. Dr. C.J.A. Punt ) |
Study ID Numbers: | CAIRO2 |
Study First Received: | September 13, 2005 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00208546 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
capecitabine oxaliplatin bevacizumab cetuximab advanced colorectal cancer |
Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Colonic Diseases Bevacizumab Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Carcinoma Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |