A trial looking at gefitinib for people with advanced cancer of the food pipe (oesophagus) - COG Trial

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 3

This trial looked at gefitinib (Iressa) for cancer of the food pipe (oesophageal cancer) that had started to grow again after chemotherapy. This trial was supported by Cancer Research UK.

Doctors often use chemotherapy to treat oesophageal cancer that has come back after treatment (recurrence) or has spread to another part of the body. But at some point the cancer will start to grow again. It wasn’t clear what the best treatment was when this happened.

Gefitinib is a drug called a tyrosine kinase inhibitor (TKI). It works by blocking receptors on the surface of cells called 'epidermal growth factor receptors' (EGFR). Doctors hoped that by blocking these receptors, gefitinib would stop or slow down the growth of cancer cells.

Doctors hoped that gefitinib might help people to live longer with oesophageal cancer that had come back. But they didn’t know this for certain. As all treatments have side effects, it is important that people don’t have treatments that don’t work.

Half of the people in this trial had gefitinib. The other half had a dummy drug (placebo).

The aims of this trial were to

  • Find out if gefitinib helped treat oesophageal cancer that was growing again after chemotherapy
  • Learn more about the side effects of gefitinib and how they affected people’s quality of life Open a glossary item

Summary of results

The trial team found that oesophageal cancer took longer to start growing again in people taking gefitinib.

This was a phase 3 trial. It recruited 450 people. It was a randomised trial. Neither the person nor their doctor could choose or were told which group they were in. It was a double blind trial.

Half the people had gefitinib. The other half had the dummy drug (placebo).

The researchers looked at the average time people were free of cancer. They found that it was

  • 7 weeks for those who had gefitinib
  • 5 weeks for those who had the dummy drug

They also found that people who had gefitinib had less pain when swallowing.

When they looked at the average time people lived after treatment, they found little difference between the 2 groups. 

But a sub study looked at testing for the EGFR gene to try and identify a sub group of people who might benefit more from gefitinib. They tested for extra copies of the EGFR gene in the cancer cells. They found that people whose oesophageal cancer cells had extra copies did live longer when they had gefitinib.

The trial team concluded that gefitinib increased the time people were free of their cancer and also reduced their symptoms. The results from the sub study showed that there was a sub group of people who would benefit more from gefitinib as a second treatment. Testing for EGFR could be useful as a way to predict how well people with oesophageal cancer might respond to gefitinib as a first treatment.    

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 David Ferry

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Royal Wolverhampton Hospital NHS Trusts
University of Aberdeen
University of Oxford

Other information

This is Cancer Research UK trial number CRUK/07/017.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 708

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

Last reviewed:

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