“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of AZD4547 with cisplatin and capecitabine for advanced cancer (FACING)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called AZD4547 with chemotherapy for people who have
Doctors use treatments such as surgery, radiotherapy and chemotherapy to treat cancer. But sometimes cancers continue to grow despite having all the
Growth factors are natural body chemicals that control cell growth. They work by binding to receptors on the surface of cancer cells. This sends a signal to the inside of the cell, which sets off a chain of chemical reactions. AZD4547 is a type of biological therapy that works by stopping the signaling from a growth factor called fibroblast growth factor (FGF). Drugs that block growth factor signaling can stop cancer cells growing and dividing.
There is likely to be more FGF signaling when a cancer has more copies than normal of a gene called FGFR-2. So AZD4547 may work better for cancers that have an increase in FGFR-2.
The aims of the trial are to
- Find the best dose of AZD4547 to give alongside cisplatin and capecitabine chemotherapy
- Learn more about how AZD4547 works and what happens to it in your body
- See if this combination of drugs helps people with cancer of the stomach, oesophagus or gastro oesophageal junction whose tumours have an increased amount of the FGFR-2 gene
Who can enter
You may be able to enter the 1st part of this trial if you have a
You may be able to enter the 2nd part of the trial if
- You have stomach cancer, oesophageal cancer or gastro oesophageal junction cancer that cannot be removed with surgery, or treated with a combination of chemotherapy and radiotherapy
- Your cancer has an increased amount of the FGFR-2 gene – the trial doctors will ask your permission to check this by looking at some tissue that was removed when you had surgery or a
- You haven’t already had chemotherapy
And as well as the above, for either part of the trial you
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- 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
- Are over 25 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain unless this has been successfully removed with surgery and a scan shows it has not come back
- Have had major surgery, another experimental drug or any other cancer treatment in the last 4 weeks (6 weeks if you had mitomycin or a drug called a
nitrosourea) – people joining part 1 can be taking drugs called LHRH analoguessuch as goserelin (Zoladex) if they have prostate cancer
- Have not recovered from the side effects of other cancer treatment (apart from hair loss) unless these are very mild
- Have an infection that cannot be controlled with medication
- Have had a heart attack in the last 6 months or have other heart problems that are a cause for concern – the trial doctors can advise you about this
- Have had a stroke, a fit (seizure), or bleeding in your brain in the last 6 months
- Have problems with your
digestive systemthat would make it difficult for you to absorb tablets
- Have certain eye conditions including (but not limited to) macular degeneration – the trial doctors can advise you about this
- Have any other medical condition that the trial doctors think would make it unsafe for you to take part
- Are known to be very sensitive to cisplatin
- Have a condition called DPD deficiency or are known to be very sensitive to capecitabine
- Have significant problems with your hearing
- Take other medication that can affect enzymes called CYP3A4 and CYP2D6 – the trial doctors can advise you about this
- Are pregnant or breastfeeding
People joining the 2nd part of the trial cannot have had any other type of cancer in the last 5 years apart from basal cell skin cancer or carcinoma in situ of the cervix that has been successfully treated.
The trial is in 2 parts. The first part of the trial recruited people with different types of cancer. The researchers wanted to find the highest dose of AZD4547 that you can have safely alongside cisplatin and capecitabine.
The first few patients taking part had a low dose of AZD4547. As long as they didn’t have any serious side effects, the next patients had a higher dose. And so on, until they found the best dose to give. This is called a dose escalation study.This part of the trial has now finished.
In the second part of the trial, the researchers want to see if having AZD4547 alongside chemotherapy helps people with advanced cancer of the stomach, oesophagus or gastro oesophageal junction. This part of 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. And neither of you will know which group you are in either. This is called a double blind trial.
- People in one group have cisplatin, capecitabine and the highest safe dose of AZD4547 that was found in the first part of the trial
- People in the other group have cisplatin, capecitabine and a dummy drug (
You have cisplatin through a drip into a vein once every 3 weeks. You have capecitabine tablets twice a day for 2 weeks, followed by a week without treatment. Each 3 week period is called a cycle of treatment. You take AZD4547 as tablets twice a day during the first 2 weeks of each treatment cycle.
You have up to 6 cycles of chemotherapy. But as long as you don’t have bad side effects, you can then carry on having AZD4547 (or placebo) on its own for as long as it helps you.
The trial team will ask you to keep a diary at home to record how many tablets you take each day. As long as you don’t have bad side effects, you can have up to 6 cycles of treatment.
During the trial, the researchers will take some extra blood samples and depending on where your cancer is, they may also ask you to have a
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination including an eye test
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- CT scan if you have not had one in the last 4 weeks
- Chest X-ray
People joining the first part of the trial have 3 hospital visits in the first week of treatment. People joining the second part of the trial have 2. During the next 5 weeks, you go to hospital at least once a week. After that, your hospital visits are once every 3 weeks until you finish treatment.
You may need to stay in hospital overnight when you have chemotherapy.
You have regular blood tests and ECGs. In the 2nd cycle of treatment, you have another eye test and an echocardiogram or MUGA scan. You have a CT scan every 9 weeks.
When you finish treatment, you go back to see the trial team about 4 weeks later.
As AZD4547 is a new drug, there may be side effects we don’t know about yet. The possible side effects include
- Skin rash
- Pain in your jaw
- Dryness affecting your eyes, mouth, throat or the inside of your nose
- Dry hair or changes to the colour of your hair
- Hair loss
- Sore mouth
- Changes to your nails
- Feeling or being sick
- Diarrhoea or constipation
- Redness on the palms of your hands or the soles of your feet
- Numbness or tingling in your hands or feet
- Tiredness (fatigue)
- Raised blood pressure
- Changes to the levels of calcium or phosphate in your blood
AZD4547 can also cause changes to your eyes such as swelling of the outer surface of your eye, or a build up of fluid behind your eyes which may affect your vision. This can be diagnosed using eye tests, which are included in the study.
You must not eat grapefruit (or drink its juice) during the trial as it can affect the way AZD4547 works.
How to join a clinical trial
Professor Jeff Evans
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
University of Glasgow
This is Cancer Research UK trial number CRUKD/11/003.