
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 chemotherapy drugs called gemcitabine and cisplatin alongside a new drug called nintedanib for invasive bladder cancer. It is for people who have the most common type of bladder cancer called transitional cell cancer.
If bladder cancer has grown into the muscle layer of the bladder, it is called invasive bladder cancer. Doctors can treat invasive bladder cancer with chemotherapy before surgery to remove the bladder. Or you may have chemotherapy before radiotherapy or a combination of radiotherapy and chemotherapy ().
Having chemotherapy before surgery or radiotherapy can help these treatments to work better. Doctors often use a combination of the chemotherapy drugs gemcitabine and cisplatin. But researchers are looking at ways to improve treatment. In this trial they are looking at a drug called nintedanib alongside gemcitabine and cisplatin.
Nintedanib (also known as BIBF 1120) is a type of biological therapy. It stops the signals that cancer cells use to grow. Some people taking part in the trial have gemcitabine and cisplatin, some have gemcitabine, cisplatin and nintedanib.
The aims of the trial are to find out
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply
This is a phase 2 trial. The researchers need 120 people to join.
It is a randomised trial. The people taking part will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
You have treatment in 3 week periods called cycles of treatment. You have gemcitabine and cisplatin through a drip into a vein.
The first day of each treatment cycle is called day 1.
If your kidneys are working well, you have :
If your kidneys aren't working well, you have:
Nintedanib and the dummy drug are capsules that you take twice a day everyday.
You have 4 cycles of treatment. When you finish treatment, your doctor will talk to you about further treatment options. You then go on to have 1 of 3 usual treatments that people have after chemotherapy for invasive bladder cancer. These include
The researchers will ask for a sample of your cancer that was removed when you had a . You will have another biopsy during your 3rd cycle of treatment and 3 months after treatment finishes if you don’t go on have surgery.
You will see the doctors and have some tests before you start treatment. The tests include
You go to the hospital twice in each 3 week cycle to have your chemotherapy. You have regular blood tests and urine tests. You have a CT scan during your 3rd cycle of treatment.
You see the trial team for a check up 3 months after surgery or when you finish radiotherapy or chemoradiotherapy. You have another CT scan 6 months later. After that you have a CT scan and see the trial team for a check up once a year for up to 5 years.
The most common side effects of nintedanib include
The most common side effects of gemcitabine include
The most common side effects of cisplatin include
We have more information about
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Syed Hussain
Boehringer Ingelheim
Clatterbridge Cancer Centre NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Liverpool
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.