
"I am glad that taking part in a trial might help others on their own cancer journey.”
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 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.
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
You may be able to enter the 1st part of this trial if
You may be able to enter the 2nd part of the trial if
As well as the above, to enter either part of the trial you must
You cannot enter either part of this trial if
As well as the above, you cannot join the 2nd part of the trial if you
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
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.
You see the trial team and have some tests before you start treatment. The tests include
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.
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
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof John Chester
Prof Chris Twelves
AstraZeneca
Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds
This is Cancer Research UK trial number CRUKD/12/009.
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”