A three arm randomised controlled trial comparing either continuous chemotherapy plus cetuximab, or intermittent chemotherapy with standard continuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer
Adding a new drug, or less chemotherapy. Are these better options for bowel cancer treatment?
What is this study about?
Over 16,000 people die from bowel cancer in the UK every year. The COIN trial aims to determine the best way of treating patients whose bowel cancer has spread. The usual treatment is to give chemotherapy continuously over a period of months. However, this often stops working after a time, or the drugs become too toxic for people to cope with. The COIN trial is looking at two alternatives to this standard treatment. One alternative is testing a new drug, cetuximab, given in addition to the standard chemotherapy. This drug may help people with bowel cancer live longer. The other option is giving the standard chemotherapy over shorter periods with breaks in between. This intermittent treatment may improve patients’ quality of life.
New data has recently emerged about the lack of effectiveness of cetuximab in patients with a mutation in their K-ras gene. The analysis of the study arm where patients are taking cetuximab compared with standard therapy will now be limited to those patients who have a normal K-ras gene in their tumour.
Type of study
Who is funding the study?
The trial is being paid for by the charity Cancer Research UK and by the Medical Research Council. The pharmaceutical company Merck & Co. is providing the new drug, cetuximab, free of charge and is also providing an educational grant to help manage the trial.
When is it taking place?
The trial finished recruiting patients in May 2008.
Where is it taking place?
Hospitals throughout the UK and Ireland.
Who is included?
People with advanced colorectal (bowel) cancer.