A trial looking at onartuzumab with chemotherapy for HER2 negative 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 a drug called onartuzumab (pronounced on-are-too-zoo-mab) 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 another part of the body and has only small amounts of a protein called HER2 (it is HER2 negative Open a glossary item ).

Doctors can use chemotherapy for stomach cancer that has spread to other parts of the body. In this trial, they are looking at adding a drug called onartuzumab.

Onartuzumab (also known as MetMab) is a type of biological therapy called a monoclonal antibody. It targets a receptor Open a glossary item called Met that is found on cancer cells. The people taking part in this study have cancer cells with large numbers of Met receptors.

The aims of the trial are to

See if onartuzumab and chemotherapy is better than chemotherapy alone for HER2 negative advanced cancer of the stomach or gastro oesophageal junction
Learn more about the side effects

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 another part of your body and it is not possible to have surgery to remove it, or other treatment to try to cure it
Your cancer cells have large amounts of a receptor called Met, but only small amounts of HER2 – the trial team will test for this
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood test results
You are at least 18 years old
You are willing to use reliable contraception during the trial and for up to 6 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

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 already had a drug that works in a similar way to onartuzumab
Have had another experimental drug in the last 4 weeks
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 and you have recovered from any side effects)
Have had major surgery in the last 4 weeks and have not fully recovered
Have damage to your nerves (peripheral neuropathy) unless it is very mild
Have diabetes that isn’t well controlled
Have problems with your digestive system (other than cancer)
Have bleeding into your digestive system
Have had a severe reaction to 5FU (or a similar drug), or have low levels of a body substance called DPD – your doctor can advise you about this
Are known to be very sensitive to any of the drugs in the trial
Have had a heart attack in the last 6 months or have certain other heart problems – the trial doctors can advise you about this
Have a serious infection or another medical condition that the trial team think could affect you taking part
Are known to be HIV positive
Have hepatitis B or hepatitis C
Have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix, non melanoma skin cancer, stage 1 womb cancer, prostate cancer that was contained within the prostate gland and was removed with surgery, or any other cancer that was successfully treated and your doctors think has been cured
Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit 800 people around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

People in one group have chemotherapy and onartuzumab
People in the other group have chemotherapy and a dummy drug (placebo )

Onartuzumab with chemotherapy for HER2 negative cancer trial diagram

On the first day of treatment, you have onartuzumab or the dummy drug through a drip into a vein. You then have chemotherapy.

You have drugs called oxaliplatin and folinic acid through a drip into a vein. This takes about 2 hours. You then have a drug called 5FU. You have a short injection into a vein, followed by a slow drip into a vein over the next 46 hours. Depending on where you are having treatment, you may be able to have this via a small portable pump that is attached to a line going into a vein in your chest (a central line).

You have this treatment every 2 weeks. Each 2 week period is called a cycle of treatment. You have 12 cycles of chemotherapy with onartuzumab or the dummy drug. If your cancer has stayed the same size or got smaller during this time, you may carry on having onartuzumab (or the dummy drug) on its own every 2 weeks. As long as you don’t have bad side effects, you can continue to have it until your cancer starts to get worse.

The trial team will ask you to fill out a questionnaire each time you have treatment and a month after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

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

Physical examination
Heart trace (ECG )
Blood tests
Urine test

If your doctor thinks it is necessary, you may also have

Chest X-ray
CT scan or MRI scan
Bone scan

The trial team will test a sample your cancer to make sure it has large numbers of Met receptors (Met positive) and only small amounts of the HER2 protein (HER2 negative). It may be possible to get a sample of tissue from when you had surgery or a biopsy Open a glossary item in the past. If not, you may need to have a biopsy when you join the trial.

You go to hospital for treatment every 2 weeks. You have regular blood tests and a CT or MRI scan every 6 weeks. You may need to have more chest X-rays or bone scans. If you carry on having the trial treatment for more than a year, you then have a scan every 3 months.

When you finish treatment, you see the trial team about a month later. You have a physical examination, more blood tests and a urine test. You may need to have another CT or MRI scan and a chest X-ray.

A member of the trial team will then contact you by phone every 3 months to see how you are. This will continue for as long as you agree to it.

Side effects

As onartuzumab is a new drug, there may be side effects we don’t know about yet. In earlier trials, side effects included

Tiredness (fatigue)
Swelling (oedema) in your arms or legs
Feeling or being sick
Loss of appetite
Muscle spasms
Tummy (abdominal) pain
Weight gain
High temperature (fever)
Changes to some blood test results

The side effects of the chemotherapy drugs in this trial include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Fatigue
Diarrhoea
Sickness
Numbness, tingling for pins and needles in your hands and feet (peripheral neuropathy) or around your mouth
Sore mouth
Hair loss
Loss of appetite
Cough
Constipation
Abdominal pain
Shortness of breath
Liver damage
High temperature (fever)
Aching muscles
High levels of sugar in your blood
Taste changes
Headache
Difficulty sleeping
Reactions such as a skin rash, itching or wheezing
Heartburn
Weight loss
Runny nose