A two-arm phase II randomised trial of intermittent chemotherapy plus continuous cetuximab and of intermittent chemotherapy plus intermittent cetuximab in first line treatment of patients with K-ras-normal (wild-type) metastatic colorectal cancer

Testing a new drug for people with advanced colorectal (bowel) cancer

What is this study about?

In the UK, approximately 36,000 people develop bowel cancer each year, making it one of the most common cancers in this country. When bowel cancer can’t be completely removed by surgery, or when the cancer has spread to somewhere else in the body, doctors may offer people chemotherapy. Although it does not cure advanced bowel cancer, chemotherapy can shrink or control it for a period. In this trial, we want to find out the best way to give people a new antibody (a drug made of protein) treatment called cetuximab (also called Erbitux) alongside their chemotherapy. Every patient in the trial will initially be treated with both chemotherapy and cetuximab. Some patients will go on to have a break from chemotherapy but continue to receive cetuximab alone. Other patients will have a break from both treatments. This trial will enable us to find out whether it is better to receive cetuximab intermittently or continuously when chemotherapy is given intermittently, and will help us to find the best way to ensure that people with advanced bowel cancer can live well for longer.

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.

Type of study

Randomised trial

Contact details

Who is funding the study?

The Medical Research Council and the pharmaceutical company Merck Serono, that manufactures cetuximab.

When is it taking place?

COIN-B closed to recruitment on 3rd June 2010, having recruited 169 KRAS wild-type patients.

Where is it taking place?

COIN-B is open to a limited number of hospitals in the UK and one hospital in Cyprus.

Who is included?

People with advanced colorectal (bowel) cancer. Main eligibility criteria include: 1. Consent for screening of an archival tumour block for determination of K-ras status, with only K-ras wild-type patients being eligible for randomisation, 2. Histologically confirmed colorectal adenocarcinoma, 3. No previous systemic palliative chemotherapy for metastatic disease. 4. Written informed consent.