COIN-B (COIN-Biological) trial is an open-label, multi-centre, randomised phase II trial, looking into how biological therapy with cetuximab (a monoclonal antibody which targets the Epidermal Growth Factor Receptor (EGFR)) might be safely and effectively added to intermittent chemotherapy.
Recruitment to the trial was temporarily suspended in May 2008 when data emerged about the lack of effectiveness of EGFR-targeted therapies in patients who have a mutation in their K-ras gene. The COIN-B protocol was amended to include screening for the presence of K-ras mutations in consenting patient’s colorectal tumour. Only patients with a normal K-ras gene will be eligible for randomisation. The trial re-opened in January 2009 in approved sites and further sites are due to open shortly. We expect to achieve the accrual target of 158 patients by screening approximately 260 patients (including the 119 patients previously enrolled and treated prior to suspension).