Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at TDM1 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.
This trial is comparing a drug called trastuzumab emtansine (TDM1) with a taxane chemotherapy drug 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 into surrounding tissue or to another part of the body. The cancer must have large amounts of a protein called
Cancers with large amounts of HER2 are called HER2 positive cancers. Doctors can treat HER2 positive cancer with drugs such as Herceptin which target the HER2 protein.
In this trial, researchers are looking at a drug called TDM1 which is a combination of Herceptin and a chemotherapy drug called DM1.
The aims of the trial are to
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) that cannot be removed with surgery
- Your cancer has spread into surrounding tissue or to another part of your body and has got worse despite having another type of treatment
- You have already had chemotherapy for advanced stomach cancer that included a
platinum drugand fluorouracil (or a similar drug)
- Your cancer has large amounts of a protein called
HER2on the cells – the trial team will test for this
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- You are at least 18 years old
- You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain and has not been treated or has been treated and is still causing symptoms (if you have had treatment for symptoms of cancer spread to your brain, this must have finished at least a month ago)
- Have already had TDM1, docetaxel or paclitaxel
- Have had any other chemotherapy, a drug that targets the HER2 protein, or an experimental drug in the last 3 weeks
- Have had more than 1 other type of chemotherapy for advanced cancer
- Have had another type of cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or stage 1 womb cancer, that was successfully treated, or any other cancer that your doctors consider to be cured
- Have damage to your nerves (peripheral neuropathy) unless this is mild
- Have already had large doses of an
anthracycline chemotherapy drug– the trial doctors can advise you about this
- Have high blood pressure that cannot be controlled with medication
- Have had a heart attack in the last 6 months or have certain other heart problems – the trial team can advise you about this
- Have had major surgery, a serious injury or significant bleeding in the last 4 weeks
- Have had a bad reaction to Herceptin or a similar drug
- Have HIV, hepatitis B or hepatitis C
- Have any other serious medical condition
- Are pregnant or breastfeeding
The trial is recruiting more than 400 people in a number of different countries. There are 2 parts.
The trial is randomised. 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.
In the first part of the trial, the researchers were looking for the best way to give TDM1. There were 3 treatment groups. People in all 3 groups had treatment through a drip into a vein.
- Group A had TDM1 every 3 weeks
- Group B had TDM1 every week
- Group C had docetaxel every 3 weeks or paclitaxel every week (your doctor decides which of these drugs would be best for you before you are put into a treatment group)
Results from this part of the trial showed that it was best to give TDM1 every week. So in the second part of the trial, there were only 2 treatment groups - either weekly TDM1 or a taxane drug.
As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you.
The trial team will ask everybody taking part to fill out some questionnaires at the beginning of each treatment cycle and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine tests
- CT scan or MRI scan
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
You may also need to have X-rays or a bone scan.
The researchers will test a sample of your cancer that was removed in the past, to see if it is
The number of hospital visits you have will depend on which treatment group you are in.
During treatment, everybody taking part has regular blood tests, a CT or MRI scan every 6 weeks, and an echocardiogram or MUGA scan every 9 weeks.
When you finish treatment, you
- See the trial team and have a CT or MRI scan between 4 and 6 weeks later
- Have an echocardiogram or MUGA scan every 6 months for the first year and then once a year for the next 3 years
If you are in one of the groups having TDM1, you have another blood test 3 months after your last dose.
You have follow up appointments with the trial team every 2 months. If you can’t go to hospital, a member of the team will contact you by phone to see how you are. This will continue until the study has completely finished.
If you stop the trial treatment for any reason other than your cancer getting worse, the trial team will ask you to carry on having scans every 6 weeks until your cancer does start to get worse.
As TDM1 is a new drug, there may be side effects we don’t know about yet. The most common known side effects are
- Tiredness (fatigue)
- Nose bleed
- Fever and chills
- Difficulty sleeping
- Feeling or being sick
- Constipation or diarrhoea
- Tummy (abdominal) pain
- Changes to the way your liver or heart works
- Difficulty breathing
- A drop in blood cells causing bleeding, bruising, tiredness and breathlessness
- Skin rash
- Dry or sore mouth
- Tingling, pain, numbness or pins and needles in your arms or legs
- Low levels of potassium in your blood
- Painful joints, muscles, back arms and legs
- A reaction to the drug causing flu like symptoms, fever, chills, shortness of breath, low blood pressure, wheezing, increased heart rate, an itchy rash and swelling of the throat
The trial team will talk to you about all the possible side effects before you agree to take part.
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 Was Mansoor
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer