Cetuximab, Capecitabine, Oxaliplatin and Bevacizumab in Advanced Colorectal Cancer

Summary

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.

Timeline

Start

2005-06

Primary completion

2009-07

Completion

2009-12

Publications

• Results Tol J, Koopman M, Rodenburg CJ, Cats A, Creemers GJ, Schrama JG, Erdkamp FL, Vos AH, Mol L, Antonini NF, Punt CJ. A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity. Ann Oncol. 2008 Apr;19(4):734-8. doi: 10.1093/annonc/mdm607. Epub 2008 Feb 13.
• Results Tol J, Koopman M, Cats A, Rodenburg CJ, Creemers GJ, Schrama JG, Erdkamp FL, Vos AH, van Groeningen CJ, Sinnige HA, Richel DJ, Voest EE, Dijkstra JR, Vink-Borger ME, Antonini NF, Mol L, van Krieken JH, Dalesio O, Punt CJ. Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. N Engl J Med. 2009 Feb 5;360(6):563-72. doi: 10.1056/NEJMoa0808268.
• Baas J, Krens L, Bohringer S, Mol L, Punt C, Guchelaar HJ, Gelderblom H. Genome wide association study to identify predictors for severe skin toxicity in colorectal cancer patients treated with cetuximab. PLoS One. 2018 Dec 17;13(12):e0208080. doi: 10.1371/journal.pone.0208080. eCollection 2018.
• van Kessel CS, Samim M, Koopman M, van den Bosch MA, Borel Rinkes IH, Punt CJ, van Hillegersberg R. Radiological heterogeneity in response to chemotherapy is associated with poor survival in patients with colorectal liver metastases. Eur J Cancer. 2013 Jul;49(11):2486-93. doi: 10.1016/j.ejca.2013.03.027. Epub 2013 May 18.
• Simkens LH, Koopman M, Mol L, Veldhuis GJ, Ten Bokkel Huinink D, Muller EW, Derleyn VA, Teerenstra S, Punt CJ. Influence of body mass index on outcome in advanced colorectal cancer patients receiving chemotherapy with or without targeted therapy. Eur J Cancer. 2011 Nov;47(17):2560-7. doi: 10.1016/j.ejca.2011.06.038. Epub 2011 Jul 29.

Drugs

Indications