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.

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1/2

This trial is looking at a drug called AZD4547 with chemotherapy for people who have solid tumours Open a glossary item 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 standard treatments Open a glossary item . 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

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 solid tumour Open a glossary item (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

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 biopsy
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 analogues such 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 system that 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.

Trial design

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 (placebo )

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 biopsy Open a glossary item before starting treatment and again about 3 weeks later. They will use these samples to look for substances called biomarkers 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.

Hospital visits

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 (ECG )
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.

Side effects

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.

We have more information about cisplatin and capecitabine in our cancer drugs section.

Recruitment start:

01/03/2012

Recruitment end:

31/01/2015

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.

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Chief Investigator

Professor Jeff Evans

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
University of Glasgow