Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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.
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
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 positiveoesophageal 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 have an adenocarcinoma of the oesophagus or adenocarcinoma of the stomach (gastric) that is
- You are to have chemotherapy before surgery to remove your cancer
- Your heart works well enough – your doctor will test for this
- You have satisfactory blood test results
- You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
advanced cancerthat 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 (
- Have a problem with your
liveror gall bladder
- 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
enzymecalled dihydropryrimidine dehydrogenase (DPD)
- Have a problem breaking down and absorbing sugar in your gut
- Are pregnant or breastfeeding
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.
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.
Dr Hugo Ford
Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)