A trial looking at irinotecan with or without cetuximab for bowel cancer that has spread (EPIC EMR 622202 - 025)

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer




Phase 3

This trial looked at irinotecan with or without cetuximab (Erbitux) for people with advanced bowel cancer.

Doctors usually treat advanced bowel cancer with chemotherapy. Irinotecan is one of the chemotherapy drugs they use.

Cetuximab is a type of biological therapy called a monoclonal antibody. Some cancer cells have receptors on the cell surface called epidermal growth factor receptors, or EGFRs. When the epidermal growth factor (EGF) attaches to the receptor, it triggers the cancer cell to keep growing. Cetuximab attaches itself to the receptor instead, and stops this process.

In this trial, some people had irinotecan and cetuximab, and some had irinotecan alone.

The aims of this trial were to find out

  • If irinotecan and cetuximab is better for bowel cancer that has spread than irinotecan alone
  • More about the side effects
  • What effect it had on quality of life

Summary of results

The research team found that cetuximab and irinotecan is better for advanced bowel cancer than irinotecan alone.

This trial recruited 1,298 people with bowel cancer that had spread and whose cancer had been tested to see if the cells had EGFRs. They had all had chemotherapy before, but their cancer had continued to grow. Of these 1,298 people,

  • 650 had irinotecan alone
  • 648 had irinotecan and cetuximab

The research team looked at how many people’s cancer responded to treatment. They found it was

  • Just over 4 out of 100 people (4.2%) who had irinotecan alone
  • Over 16 out of every 100 people (16.4%) who had irinotecan and cetuximab

They also found that the cancer stopped growing for longer when people had both treatments.

When they looked at how long people had lived overall, they found the 2 groups were similar. But this could be because of treatment they had after the trial. Nearly half of the people who had irinotecan alone on the trial went on to have cetuximab at a later date.

The research team also looked at the effect treatment had on quality of life. They found that quality of life was similar for both groups at the start of the trial. Although it dropped a bit for both groups after treatment, the group that had irinotecan and cetuximab had a better quality of life than the group that had irinotecan alone. In particular, they had less pain and sickness.

The research team concluded it was useful to add cetuximab to irinotecan for advanced bowel cancer. And that it affected quality of life less than irinotecan alone.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor D. Cunningham

Supported by

Merck Pharmaceuticals

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 484

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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