A trial comparing Iressa and methotrexate for head and neck cancer (1839IL/0704)

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasal and paranasal sinus cancer
Nasopharyngeal cancer
Pharyngeal cancer




Phase 3

This trial was looking to see whether a drug called gefitinib worked better than methotrexate for squamous cell cancers of the head and neck.

Many head and neck cancers are squamous cell cancers. Squamous cells are the flat, skin like cells that cover the inside of the mouth, nose, larynx and throat.

Some cancer cells have too many growth factor receptors (called ‘epidermal growth factor receptor’ or EGFR) on their surface. When these receptors are triggered, they activate an enzyme Open a glossary item called tyrosine kinase Open a glossary item. The activated tyrosine kinase tells the cancer cells to grow and divide, so they keep making new cells.

Gefitinib (also known as Iressa or ZD 1839) is a type of drug called a tyrosine kinase inhibitor. These drugs stop tyrosine kinase working. Doctors hoped that if gefitinib stopped tyrosine kinase working, it would stop the growth of cancer cells. But they didn’t know how well it would work for head and neck cancer that had come back after treatment.

Head and neck cancer that has come back can be difficult to treat. There is no specific standard treatment Open a glossary item, but most doctors give a chemotherapy drug called methotrexate. This trial was comparing methotrexate to 2 different doses of gefitinib to find out which treatment was best.

The aims of this trial were to find out

  • How well gefitinib worked for head and neck cancer compared to methotrexate
  • Which of the 2 doses of gefitinib was the best to use
  • More about the side effects

Summary of results

The researchers found that gefitinib did not work as well as methotrexate for squamous cell cancers of the head or neck that had come back after treatment.

  • The trial recruited 486 people
  • A third of the people had a low dose of gefitinib
  • A third had a higher dose of gefitinib
  • A third had methotrexate

In all 3 groups, the cancer responded to the treatment in some people. But the average length of time that people lived after treatment was shorter with either dose of gefitinib than it was for people who had methotrexate.

Fewer than 1 in 5 people who had gefitinib lived for more than a year. This compared with about 1 in 4 people who had methotrexate.

Side effects of gefitinib included a skin rash and diarrhoea. Side effects of methotrexate included a sore mouth and sickness.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. 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

Dr Simon Stewart

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Last review date

CRUK internal database number:

Oracle 458

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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