A trial looking at chemotherapy with or without cetuximab for people over the age of 70 with bowel cancer that has spread (EORTC 40085)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer




Phase 2

This trial is looking at a drug called cetuximab alongside fluorouracil (5FU) chemotherapy. The trial is for people aged at least 70 who have bowel cancer that has spread elsewhere in the body.

Doctors often treat people under the age of 65 who have bowel cancer that has spread with 5-fluorouracil (5FU) and leucovorin (folinic acid) and cetuximab. But older people often have 5FU and leucovorin alone.

Cetuximab is a type of biological therapy called a monoclonal antibody. Some bowel cancers have a change to a gene called a K-RAS mutation Open a glossary item. We know from research that cetuximab doesn't help people who have this mutation. So, you can only take part in this trial if you have a normal K-RAS gene.

The researchers want to see if adding cetuximab to 5FU and leucovorin will be a better treatment for older people with bowel cancer than having 5FU and leucovorin alone.

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have bowel cancer that has spread to another part of your body (metastatic colorectal cancer)
  • Have a normal K-RAS gene
  • Are aged 70 or older
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Had chemotherapy before your cancer spread (the treatment must have been completed at least 6 months before you start the trial)
  • Have satisfactory blood test results
  • Are willing to use contraception during treatment and for 1 month afterwards if there is a possibility your partner could become pregnant

You cannot join this trial if any of these apply. You

  • Have had chemotherapy for your bowel cancer since it has spread
  • Have had radiotherapy to any area of your body where your cancer has spread to
  • Have already had cetuximab or similar drugs
  • Have taken part in another clinical trial testing a new drug or treatment in the last 4 weeks
  • Have any side effects from previous treatment that are causing problems
  • Have had a heart attack in the last 12 months or have any other problems with your heart that your doctor thinks may affect you taking part in the trial
  • Have had a stroke (CVA) or mini stroke (a transient ischemic attack or TIA) in the last 12 months
  • Have another medical condition or mental health problem that could affect you taking part in this trial (the trial team can advise you about this)
  • Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or early stage prostate cancer that was successfully treated
  • Drink alcohol or take drugs and your doctor thinks this is a cause for concern

Trial design

This is an international phase 2 trial. The researchers need about 55 people in the UK to join the trial. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer.

  • People in one group will have 5-fluorouracil (5FU) and leucovorin (folinic acid)
  • People in the other group will have 5FU, leucovorin and cetuximab

EORTC 40085 trial diagram

On the first day of your treatment, you have 5FU and leucovorin with or without cetuximab through a drip. You will then have 5FU as a continuous infusion via a small pump over 3 days. You may be able to go home with the pump in place and then come back to the hospital to have it removed.

You have treatment every 2 weeks. Each 2 week period is called a cycle of treatment.

You can have treatment

  • For as long as it is helping you and your cancer has not grown
  • Until you decide you don’t want to continue with the trial
  • Until your trial doctor feels its best for you to stop the trial

The researchers will ask you to fill in a questionnaire. It will ask how you have been and about any side effects you have had. You fill it in before starting treatment, 4 times during the trial and then when you finish treatment. This is called a quality of life study.

The researchers may ask you to give some extra blood samples. They may also want some tissue samples from when you had surgery or a biopsy Open a glossary item in the past. They won’t ask you to have further surgery or a new biopsy.

They will use the samples to study your cancer and learn more about how the drugs in the trial affect the cancer. If you don’t wish to take part in this extra research, you don’t have to. You can still take part in the trial.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

During treatment you will have regular blood tests and physical examinations. You have a CT scan or X-rays 6 weeks after you start treatment and then every 2 months.

If the bone scan you have before you start treatment shows that the cancer has spread to your bones, you will have a bone scan around the same time you have either a CT scan or X-rays.

After finishing treatment you see the doctor a month later for a physical examination and blood tests.

If you finish treatment for any other reason than your cancer getting worse you will visit the hospital every 8 weeks. You will have a physical examination, blood tests and either a CT scan or X-rays. This will continue until your cancer gets worse.

Side effects

The common side effects of cetuximab include

The most common side effects of 5-fluorouracil (5FU) and leucovorin (folinic acid) include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Tiredness (fatigue)
  • A sore mouth
  • Diarrhoea

We have more information about cetuximab and 5FU and leucovorin.

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

Dr Richard Adams

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
Merck KGaA
NIHR Clinical Research Network: Cancer

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11579

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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