A trial of chemotherapy and nintedanib for people with invasive bladder cancer (NEOBLADE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bladder cancer

Transitional cell cancer

Status:

Closed

Phase:

Phase 2

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.

More about this trial

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 (chemoradiotherapy Open a glossary item ).

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

Which drug combination works best for invasive bladder cancer
How well treatment works for people whose kidneys aren’t working well
More about the side effects

Who can enter

You may be able to join this trial if all of the following apply

You have transitional cell bladder cancer that has grown into the muscle layer of the bladder or beyond (stage T2 to T4a) but has not spread into your lymph nodes or to anywhere else in your body
You can have gemcitabine and cisplatin
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Your kidneys are working well or they have mild to moderate problems filtering urine
You have satisfactory blood test results
You are at least 18 years old
You are willing to use reliable contraception during the trial and for up to 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply

You have any other cancer which means you can’t have the treatment in this trial (the trial team can tell you more about this)
You are taking medication to thin your blood such as warfarin. You might still be able to join if you are having low dose heparin or aspirin
You are sensitive to nintedanib, anything it contains, peanuts or soya
You have any other medical condition that the trial team think could affect your taking part
You are pregnant or breastfeeding

Trial design

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.

People in one group have gemcitabine, cisplatin and nintedanib
People in the other group have gemcitabine, cisplatin and a dummy drug (placebo )

NEOBLADE trial diagram

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 :

gemcitabine on day 1 and day 8
cisplatin on day 1

If your kidneys aren't working well, you have:

gemcitabine on day 1 and day 8
cisplatiin on day 1 and day 8 (split dose cisplatin)

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

Surgery to remove your bladder
Radiotherapy
Chemoradiotherapy

The researchers will ask for a sample of your cancer that was removed when you had a biopsy Open a glossary item . 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.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

A physical examination
Blood tests
A heart trace (ECG )
CT Scan
Urine tests

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.

Side effects

The most common side effects of nintedanib include

Diarrhoea
Feeling or being sick
Changes to the way your liver works
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

The most common side effects of gemcitabine include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Skin rash or itching
Changes to the way your liver works
Hair loss
Small amounts of blood and protein in your urine
High temperature (fever) and chills
Swelling in your arms and legs due to a fluid build up

The most common side effects of cisplatin include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Kidney problems
High temperature and chills

We have more information about

Recruitment start:

01/09/2014

Recruitment end:

31/08/2018

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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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Syed Hussain

Supported by

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

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