A trial looking at different doses of Herceptin with chemotherapy for advanced HER2 positive cancer of the stomach or cancer where the stomach meets the oesophagus (gastro oesophageal junction cancer)

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

Cancer type:

Oesophageal cancer

Stomach cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at different doses of trastuzumab (Herceptin) alongside chemotherapy for stomach cancer, or cancer where the food pipe (oesophagus) meets the stomach (gastro oesophageal junction cancer). The people taking part have cancer that has spread to at least 2 other places in the body and has large amounts of a protein called HER2 Open a glossary item .

Doctors can use a biological therapy drug called Herceptin with chemotherapy for stomach cancer or gastro oesophageal cancer that has spread to other parts of the body. It only works for people whose cancer cells have large amounts of a protein called human epidermal growth factor receptor 2 (HER2). This is known as HER2 positive cancer.

In this trial, researchers want to see if having a higher dose of Herceptin alongside chemotherapy will help people more than the standard dose that is currently used.

The aims of the trial are to find out

How different doses of Herceptin affect people with HER2 positive cancer of the stomach or gastro oesophageal junction
See if a higher dose of Herceptin stays in the blood for longer and helps people more than the standard dose

Who can enter

You may be able to enter this trial if

You have stomach cancer or cancer where the food pipe (oesophagus) meets the stomach (gastro oesophageal junction cancer)
Your cancer has spread to at least 2 other parts of your body including your liver or your lungs (or both)
Your cancer has large amounts of a protein called HER2 on the cells – the trial team will test for this
You have satisfactory blood test results
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You are at least 18 years old
You are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have cancer spread to your brain
Have already had chemotherapy for stomach or gastro oesophageal cancer that has spread into local tissue or to another part of your body (you can take part if you had chemotherapy for cancer that had not spread, as long as treatment finished at least 6 months ago)
Have had surgery to remove all or part of your stomach as treatment for your cancer
Have already had a drug that targets the HER2 protein
Have already had a platinum chemotherapy drug
Have had radiotherapy in the last 4 weeks (or in the last 2 weeks if it was radiotherapy to treat cancer spread to the bones)
Have had major surgery in the last 4 weeks and have not completely recovered
Have had another experimental treatment in the last 4 weeks
Have a feeding tube or have problems with the upper part of your digestive system that means you may not be able to absorb drugs you take by mouth
Have problems with bleeding in your digestive system
Have not recovered from side effects of other cancer treatment unless they are mild (apart from hair loss or damage to your nerves from treatment more than 5 years ago)
Have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix or squamous cell skin cancer
Have high blood pressure that cannot be controlled with medication or certain heart problems – the trial team can advise you about this
Get breathless or need oxygen
Take steroids unless it is a low dose, or you are only taking them for a short time - you can take part if you use a steroid inhaler
Have hearing problems
Have low levels of a body substance called DPD – your doctor can advise you about this
Have another serious medical condition
Are known to be HIV, hepatitis B or hepatitis C positive
Are known to be very sensitive to any of the drugs in the trial
Are pregnant

Trial design

This phase 3 trial will recruit about 400 people. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in one group have the standard dose of Herceptin. People in the other group have a higher dose.

You have Herceptin and cisplatin through a drip into a vein once every 3 weeks. You take capecitabine tablets every day for 2 weeks, followed by a week without treatment. Each 3 week period is called a cycle of treatment.

After 6 cycles of treatment, you stop having cisplatin and capecitabine. But as long as you don’t have bad side effects, you can carry on having Herceptin alone for as long as it helps you.

The trial team may ask you to take part in a sub study looking at the amount of Herceptin in your blood at different times. This is called pharmacokinetics Open a glossary item . If you agree to take part, you give a number of extra blood samples before and after each dose of Herceptin. You don’t have to take part in this study if you don’t want to. You can still take part in the main trial.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Urine tests
Chest X-ray
CT scan
Heart trace (ECG )
Heart ultrasound (echocardiogram ) or MUGA scan

The researchers will test a sample of your cancer that was removed in the past, to see if it is HER2 positive.

During treatment, you go to hospital every 3 weeks. You have

Blood tests before each cycle of treatment
A CT scan every 6 weeks
A heart ultrasound or MUGA scan every 3 months

When you finish treatment, you see the trial team between 4 and 5 weeks later. You have a heart ultrasound or MUGA scan 4 times in the following 2 years.

You have a CT scan every 6 weeks until your cancer starts to grow again. During this time, the trial team will contact you by phone every 3 months to see how you are.

Side effects

The side effects of Herceptin include

A reaction to the drug causing a high temperature (fever), chills and flu like symptoms
Pain – this may affect your tummy (abdomen), chest, throat, muscles or joints
Indigestion or heart burn
Diarrhoea or constipation
Feeling or being sick
Weakness
Watery or swollen eyes
Runny or bleeding nose
Skin rash
Loss of appetite
Difficulty sleeping
Dizziness
Headache
Shortness of breath
Cough
Red and sore mouth
Tiredness (fatigue)
Cracked nails
Swelling in your arms or legs
Hair loss