
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
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 including stomach cancer, food pipe (oesophageal) cancer, or cancer at the point where the food pipe joins the stomach (gastro oesophageal junction cancer). This trial is supported by Cancer Research UK.
Doctors use treatments such as surgery, radiotherapy and chemotherapy to treat cancer. But sometimes cancers continue to grow despite having all the . Researchers are looking for new drugs to help people in this situation. In this trial, they are looking at a new drug called AZD4547 alongside the chemotherapy drugs cisplatin and capecitabine.
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
You may be able to enter the 1st part of this trial if you have a (any cancer apart from leukaemia or lymphoma) and there is no other standard treatment available for you.
You may be able to enter the 2nd part of the trial if
And as well as the above, for either part of the trial you
You cannot enter this trial if you
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.
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 before starting treatment and again about 3 weeks later. They will use these samples to look for substances called
to help them understand more about how AZD4547 works. If you don’t want to have the extra biopsies, you don’t have to. You can still take part in the trial.
You will see the doctors and have some tests before you start treatment. The tests include
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
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.
We have more information about cisplatin and capecitabine in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Jeff Evans
AstraZeneca
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.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”