A trial of cetuximab with or without irinotecan for advanced bowel cancer (ICE CREAM)

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Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer

Status:

Results

Phase:

Phase 2

This trial looked at cetuximab on its own or with irinotecan for bowel cancer that had spread to another part of the body (advanced bowel cancer).

More about this trial

Doctors often use chemotherapy to treat advanced bowel cancer. One of the drugs they use is irinotecan (Campto).

They can also use a type of targeted cancer drug called cetuximab (Erbitux). People often have this alongside chemotherapy, but researchers wanted to see how well it worked on its own. 

The research team looked at how well these treatments worked for people with and without changes (mutations) in specific genes. They think that changes in genes may affect how well treatments work.

In this trial some people had cetuximab alone, some had it with irinotecan.

Summary of results

In 2017 the research team published some results looking at how well these treatments worked for people with no changes (mutations) in 4 specific genes. The genes are called KRAS, NRAS, BRAF and P13KCA.  
 
Genes which don’t have any mutations are called wild type genes. Cancer that doesn’t have a mutation in these 4 genes is called quad wild type cancer. 
 
They recruited 46 people with no changes in these 4 genes, and:
  • 21 had cetuximab
  • 25 had cetuximab and irinotecan
The trial team looked at how well the treatment worked and found that that cancer:
  • got smaller in 1 out of 10 people (10%) who had cetuximab alone
  • got smaller or went away completely in just under 4 out of 10 people (38%) who had cetuximab and irinotecan
They looked at how many people’s cancer had not started to grow again 6 months after joining the trial. This was:
  • more than 1 out of 10 people (14%) who had cetuximab alone
  • just over 4 out of 10 people (41%) who had cetuximab and irinotecan
They also looked at the number of people who had side effects which could be classed as serious, and it was:
  • more than 2 out of 10 people (23%) who had cetuximab alone
  • 5 out of 10 (50%) who had cetuximab and irinotecan
When they looked at the quality of life of those who took part, they found that there was no difference between the two groups.
 
In a separate analysis in 2017, they looked at 51 people who had a change (mutation) in a specific gene called KRAS G13D. They wanted to see if cetuximab and irinotecan worked better for this group of people than cetuximab alone. They found that there was little difference between the two groups. 
 
Conclusion
The research team concluded that cetuximab and irinotecan worked better than cetuximab alone, for people with quad wild type bowel cancer that had spread. But not for people with a change in the KRAS G13D gene.
 
We have based this summary on information from the research team. 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 research 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

Dr Harpreet Wasan

Supported by

Australasian GastroIntestinal Trials Group (AGITG)
Experimental Cancer Medicine Centre (ECMC)
Imperial College Healthcare NHS Trust
Merck Serono
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

10621

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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