Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of cetuximab with or without irinotecan for advanced bowel cancer (ICE CREAM)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
If bowel cancer has spread to other parts of the body, doctors usually treat it with chemotherapy. A biological therapy drug called cetuximab (also known as Erbitux) is also licensed in the UK for people who have bowel cancer that has spread. You usually have it alongside chemotherapy, but researchers want to see how well it works on its own. In this trial, some people have cetuximab alone, some have it alongside a chemotherapy drug called irinotecan.
More about this trial
Some bowel cancers have changes to a gene called K-RAS. We know from research that cetuximab doesn't help people who have changes to this gene, so you are usually only offered treatment with cetuximab if you have a normal K-RAS gene.
But researchers want to find out if cetuximab helps people with advanced bowel cancer that has a specific change to the K-RAS gene called a G13D
Everybody taking part has bowel cancer that has spread and has got worse despite having chemotherapy.
The aims of the trial are to see
- If cetuximab works better on its own or alongside irinotecan for advanced bowel cancer with a normal K-RAS gene
- How both treatments affect people’s
quality of life
Who can enter
You may be able to enter this trial if you
- Have bowel cancer that has spread to another part of your body, can be seen and measured on a CT scan and can’t be removed with surgery
- Have cancer that has a normal K-RAS gene (earlier in the trial, people who have bowel cancer with a specific change to the K-RAS gene called a G13D mutation could take part)
- Have already had chemotherapy with the following drugs and your cancer got worse during treatment (or within the next 6 months), or you couldn’t continue having the drugs because of bad side effects – irinotecan and oxaliplatin and at least 1 of the following fluorouracil, capecitabine, raltitrexed or tegafur-uracil
- Are able to have more irinotecan (you can check this with your doctor)
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain and hasn’t been treated or is causing symptoms – you may be able to take part if it has been treated and has not got any worse for at least a month
- Have already had cetuximab or other drugs that target a protein called EGFR such as panitumumab, gefitinib or erlotinib
- Have certain types of lung disease – the trial doctor will look at the results of your CT scan to check for this
- Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or superficial bladder cancer that has been successfully treated
- Have had a heart attack in the last year or have certain other heart problems – the trial team can advise you about this
- Have any other illness or condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This phase 2 trial will recruit 100 people in Australia, Italy, Spain and the UK. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You have cetuximab once a week through a drip into a vein. The first time it takes about 2 hours. From then on, it takes about an hour each time.
People in group B also have irinotecan. You have it through a drip into a vein once every 2 weeks. This takes 1 to 2 hours each time.
As long as you don’t have bad side effects, you can carry on having treatment for as long as it is helping you.
The trial team will ask you to fill out some questionnaires
- Before you start treatment
- Every week for the first 3 months of treatment
- Every month for the rest of the time you have treatment
- At the end of treatment
- Every 4 weeks for a year afterwards
The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
The trial team will get a sample of your cancer that was removed when you had surgery or a
You go to hospital once a week for treatment. You have regular blood tests. You have a CT scan every 6 weeks.
When you finish treatment, you see the trial team and have a physical examination and blood tests. You then see them every 4 weeks for a year.
The most common side effects of cetuximab include
- Skin reactions such as a rash, itching, flaking or redness
- Muscle cramps or spasms
- Sore mouth
- Sores in your nose that can be painful or bleed
- A change to the way your liver works
Some people have a reaction when they have cetuximab. This can cause itching, shortness of breath, wheezing, a sudden drop in blood pressure, swelling around the mouth or eyes, fast pulse and sweating. You have medication beforehand to try to prevent a reaction and the trial team will monitor you closely while you’re having cetuximab.
The most common side effects of irinotecan include
- Diarrhoea which can be severe
- Increased saliva production
- Watery eyes
- Tummy (abdominal) cramps
- Flushing and a slow heart beat
- Feeling or being sick
- Tiredness (fatigue)
- Redness of swelling on the palms of your hands or the soles of your feet
- Hair thinning or hair loss
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
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.
Dr Harpreet Wasan
Australasian GastroIntestinal Trials Group (AGITG)
Experimental Cancer Medicine Centre (ECMC)
Imperial College Healthcare NHS Trust
NIHR Clinical Research Network: Cancer