A trial of AZD4547 alongside chemotherapy for solid tumours such as bladder cancer (FIESTA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called AZD4547 with cisplatin and gemcitabine for solid tumours including bladder cancer. A 
is any type of cancer apart from leukaemia or lymphoma. This trial is supported by Cancer Research UK.
More about this trial
Doctors use the chemotherapy drugs cisplatin and gemcitabine to treat different types of cancer. The combination of these 2 drugs is a for the most common type of bladder cancer, called transitional cell cancer.
Researchers are looking for ways to improve cancer treatment. In this trial, they are looking at a drug called AZD4547.
AZD4547 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
Studies in the laboratory suggest that AZD4547 may make cancer cells more sensitive to gemcitabine or cisplatin. But this is the first trial looking at this particular combination of drugs in people.
The aims of the trial are to
- Find the highest dose of AZD4547 that you can have safely alongside cisplatin and gemcitabine
- See if the combination of AZD4547, cisplatin and gemcitabine helps people with transitional cell bladder cancer that has grown into surrounding tissues or spread to another part of the body
Who can enter
You may be able to enter the 1st part of this trial if
- You have any
solid tumour that has grown into surrounding body tissues or spread to another part of your body - Your doctor thinks gemcitabine and cisplatin is an appropriate treatment for you
- There are no better
standard treatments available
You may be able to enter the 2nd part of the trial if
- You have transitional cell bladder cancer (or transitional cell cancer of the renal pelvis, ureter or urethra) that has spread into surrounding tissue or to another part of your body
- Your cancer can be measured on a scan
As well as the above, to enter either part of the trial you must
- Be at least 25 years old
- Be 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
- Be 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 either part of this trial if
- There are other treatments available that aim to cure your cancer
- You have already had AZD4547 or another drug that blocks a growth factor called FGFR
- You have had major surgery or another experimental drug in the last month
- You have had chemotherapy or other anti cancer drugs in the last 3 weeks
- You have had radiotherapy involving more than a third of your
bone marrow in the last 4 weeks (your doctor can advise you about this) or radiotherapy for symptoms in the last 2 weeks - You have not recovered from the side effects of earlier treatment (apart from hair loss) unless they are very mild
- You have cancer that has spread to your brain or spinal cord (central nervous system) unless this has been successfully treated, is not causing symptoms and you have not taken steroids for at least 4 weeks
- You cannot absorb tablets for any reason
- You are known to be allergic to any of the drugs in the trial
- You cannot have cisplatin or gemcitabine for any reason
- You have a bad infection, certain heart problems or certain eye conditions – the trial team can advise you about this
- You have any other serious medical condition that the trial team think could affect you taking part
- You are known to be HIV, hepatitis B or hepatitis C positive
- You are pregnant or breastfeeding
As well as the above, you cannot join the 2nd part of the trial if you
- Have already had a treatment that reaches your whole body (systemic treatment) for
advanced cancer - you may be able to take part if you had chemotherapy before or after surgery to try to stop your cancer coming back, as long as you finished the treatment at least 6 months before there was any sign of your cancer getting worse - Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or prostate cancer that is completely contained within the prostate gland
Trial design
This phase 1 trial will recruit up to 44 people in the UK.
Everybody taking part has 3 week cycles of treatment. You can have up to 6 cycles of treatment, lasting more than 4 months all together.
Everybody joining the first part of the trial has AZD4547, cisplatin and gemcitabine. On the 1st day of each treatment cycle, you have gemcitabine and cisplatin through a drip into a vein. On the 8th day, you have gemcitabine alone. You take AZD4547 tablets twice a day for the first 2 weeks of each treatment cycle. You then have a week without any treatment.
The first few patients taking part will have a low dose of AZD4547. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study. Please note that part 1 of the trial has now closed.
The 2nd part of the trial is randomised. The people taking part are put into 1 of 2 treatment groups by computer. Neither you nor your doctor can decide which group you are in.
People in one group have cisplatin, gemcitabine and the highest safe dose of AZD4547 that is found in the 1st part of the trial. People in the other group have cisplatin and gemcitabine alone.
The trial team will ask everybody taking part to keep a diary. In this, you note down exactly when you take your AZD4547 tablets.
They will also ask you about
- Having 2 MRI scans called dynamic contrast enhanced MR (DCE-MR), to learn more about how your cancer responds to treatment
- Giving extra blood and urine samples that will be used for future research
- Giving permission for the trial team to get and study a sample of your cancer that was removed when you had surgery or a
biopsy
You don’t have to have the scans or give the samples for research if you don’t want to. You can still take part in the trial.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Heart trace (
ECG ) - CT scan
- Tests to see how well your kidneys are working
You have an eye examination and a scan called optical coherence tomography (OCT). This scan takes pictures of the inside of your eye. You may have drops put in your eyes for the test. It is not painful and should only take a few minutes.
You also have a test called a Schirmer’s test to measure the amount of tears you produce. You have a small strip of paper put inside your lower eyelid for 5 minutes. This can be uncomfortable and may cause some irritation to your eye.
You go to hospital almost every week during the trial treatment. You have a physical examination at each visit and you may also have blood tests.
You have a CT scan after the 3rd cycle of treatment and when you finish treatment. You may also need to have a chest X-ray.
People joining the 1st part of the study will have some extra blood tests during the first 2 treatment cycles. The researches use these blood samples to learn more about what happens to the drugs in your body.
During the trial, everybody has more eye tests as described above and you may have other tests or scans if your doctor thinks these are necessary for you.
Side effects
As AZD4547 is quite a new drug, and this is the first time patients are having it at the same time as cisplatin and gemcitabine, there may be side effects we don’t know about yet. The known side effects of AZD4547 include
- Changes to your eyes which may affect your vision – it is important that you tell the trial doctors if you notice any change in your vision
- Dryness or irritation of your eyes
- Changes to the way your kidneys work
- Sore or dry mouth
- Changes to your nails
- Extra growth of eye lashes or eyebrows
You must not eat grapefruit or Seville oranges (or drink their juices), or take St John’s wort during the trial, as these can affect the way AZD4547 works.
We have more information about the side effects of cisplatin and gemcitabine.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Prof John Chester
Prof Chris Twelves
Supported by
AstraZeneca
Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds
Other information
This is Cancer Research UK trial number CRUKD/12/009.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
