A trial looking at lapatinib with chemotherapy for cancer of the food pipe and stomach (LEO)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Oesophageal cancer
Stomach cancer




Phase 2

This is a trial looking at lapatinib with chemotherapy for cancer of the oesophagus (food pipe) and cancer of the stomach. It is for people whose cancer is HER2 positive Open a glossary item. This means the cancer cells have tested positive for a protein called HER2.

Doctors often treat oesophageal and stomach cancer with chemotherapy and surgery. Oxaliplatin and capecitabine are 2 of the drugs that doctors can use.

Lapatinib (Tyverb) is a biological therapy called a tyrosine kinase inhibitor (TKI). It works by blocking receptors on cancer cells that trigger the growth of cells.  One of the receptors lapatinib blocks is called HER2. The researchers think that lapatinib may help people with HER2 positive oesophageal and stomach cancer.

The aims of this trial are to find out if

  • Lapatinib can help people with HER2 positive Open a glossary item oesophageal and stomach cancer
  • It helps to start lapatinib before chemotherapy

Who can enter

You may be able to enter this trial if you are being treated at  the Addenbrooke’s Hospital, Cambridge or the University College Hospital, London and

You cannot enter this trial if you

  • Have advanced cancer Open a glossary item that cannot be removed with surgery
  • Have had chemotherapy, lapatinib or other anti cancer treatment
  • Have had a heart attack in the last year or have another significant heart problem
  • Have a lung disease that causes serious concern – you can check this with your doctor
  • Have moderate to severe damage to the nerves of your hands or feet (peripheral neuropathy Open a glossary item)
  • Have a problem with your liver Open a glossary item or gall bladder Open a glossary item
  • Are HIV, hepatitis B or hepatitis C positive
  • Have had another experimental drug as part of a clinical trial in the last month
  • Are sensitive to the drugs used in this trial
  • Have a condition where your body does not make enough of the enzyme Open a glossary item called dihydropryrimidine dehydrogenase (DPD)
  • Have a problem breaking down and absorbing sugar in your gut
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 13 people. Everyone will have lapatinib, oxaliplatin and capecitabine.

You start having lapatinib alone for 10 days. Then you have lapatinib, capecitabine and oxaliplatin.

Lapatinib is a tablet. You take it once a day in the morning an hour before food or an hour after food.

Capecitabine is a tablet. You take it twice a day no more than 30 minutes after having a meal and with plenty of water. You take it for 2 weeks and then have 1 week of not taking it.

You have oxaliplatin through a drip into a vein. This usually takes 2 hours but can take up to 6 hours if you need to have it more slowly because of side effects. You have it once every 3 weeks. This 3 week period is called a cycle of treatment.

You have 3 cycles of treatment. Your doctor will then talk to you about having surgery to remove your cancer. If you have surgery, this will be about 4 to 6 weeks after finishing your lapatinib, capecitabine and oxaliplatin.

The researchers will take some tissue samples from your cancer after having lapatinib alone for 10 days. If you have surgery they will also take another sample of the tissue. They will compare these 2 samples to see if the lapatinib has switched off the HER2 receptors.

Hospital visits

You see the doctor and have some tests before taking part in this trial. These tests include

After 10 days of lapatinib alone you have a PET-CT scan and an endoscopy.

At the end of chemotherapy you have a CT scan.

Side effects

The side effects of lapatinib include

We have more information about lapatinib, capecitabine and oxaliplatin in our Cancer drugs section.

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 Hugo Ford

Supported by

Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8475

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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