A trial of imgatuzumab for bowel cancer that has spread to another part of the body

Cancer type:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Secondary cancers

Status:

Results

Phase:

Phase 2

This trial looked at a drug called imgatuzumab for people with bowel cancer that had spread to other parts of the body (advanced bowel cancer).

More about this trial

Bowel cancer that spreads to other parts of the body is called advanced bowel cancer. The usual treatment for this is different combinations of cancer drugs. One possible combination is FOLFIRI. This includes the drugs:

irinotecan
fluorouracil
folinic acid

Cetuximab (Erbitux) is also a possible treatment for advanced bowel cancer. It is a type of targeted cancer drug called a monoclonal antibody. Cetuximab works by recognising and finding specific proteins that tell cancer cells to divide and grow. But it doesn’t work for everyone with bowel cancer.

Doctors are looking for ways to improve treatment for people with advanced bowel cancer. In this trial, they looked at a drug called imgatuzumab.

Laboratory research had shown that imgatuzumab might slow tumour growth. It is a type of monoclonal antibody. Doctors think that imgatuzumab helps the immune system Open a glossary item

to recognise and attack the cancer.

This trial started in 2011 and these results were published in 2015. The main aim of this trial was to find out how well imgatuzumab works for people with advanced bowel cancer.

Summary of results

The trial doctors concluded that imgatuzumab does not help people with advanced bowel cancer.

169 people took part in this phase 2 trial. Everyone was having treatment for the 2nd time for advanced bowel cancer.

Treatment

Doctors asked everyone to give a tissue sample (a biopsy Open a glossary item

) to look for changes (mutations) in the KRAS gene Open a glossary item

. Based on this result, everyone was put into treatment groups.

Group A was for people who didn’t have any changes in the KRAS gene. Group B was for people who had changes in the KRAS gene.

People in treatment group A were then put into 1 of 2 groups at random:

imgatuzumab and FOLFIRI (group 1)
cetuximab and FOLFIRI (group 2)

And people in treatment group B were put into 1 of 2 groups at random:

imgatuzumab and FOLFIRI (group 3)
FOLFIRI alone (group 4)

Neither they nor their doctor could choose which group they were in.

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Results

Doctors looked at how well imgatuzumab worked. To do this, they looked at how long people lived before their cancer started to grow again. This is called progression free survival. Doctors found that it was around:

seven months for group 1
six months for group 2
five months for group 3
four months for group 4

Side effects

Doctors looked at the moderate and severe side effects people had. These included:

skin rash
low levels of magnesium in the blood
an increased risk of infection (neutropenia)

People who had imgatuzumab (group 1 and group 3) had more problems with skin rashes and had lower levels of magnesium. And people who had cetuximab (group 2) had worse neutropenia.

Conclusions

The trial doctors concluded that adding imgatuzumab to FOLFIRI does not help people with advanced bowel cancer, with or without changes in the KRAS 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.