“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at axitinib for kidney cancer that has spread (A-Predict)
This trial is looking at a new drug called axitinib to treat kidney cancer (renal cell cancer) that has spread to another part of the body. This study is for people diagnosed with kidney cancer that has already spread and who have not had treatment yet.
Doctors can treat advanced kidney cancer with surgery to remove the kidney, but this is not always possible.
In this trial doctors want to use a new drug called axitinib in people with kidney cancer that can’t be removed with surgery.
Axitinib is a new type of biological therapy called a tyrosine kinase inhibitor (TKI for short). It works by blocking the growth of new blood vessels. Cancer cells need their own blood vessels to get the food and oxygen they need in order to grow and multiply. If growth of new blood vessels is blocked, cancer cells may starve and die.
The aims of this trial are to find out
- If axitinib can help treat people with advanced kidney cancer who have not had surgery
- More about the side effects
- More about how axitinib works in kidney cancer
Who can enter
You may be able to enter this trial if you
- Have kidney cancer that has spread to another part of your body (is advanced) and is clear cell type
- Are unable to have surgery to remove your kidney (a nephrectomy)
- Have cancer that can be measured on a CT scan
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- Have satisfactory blood and urine test results
- Are willing to use reliable contraception during treatment if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have already had treatment for your kidney cancer that reached your whole body (
- Have high blood pressure that cannot be controlled with tablets
- Have cancer that has spread to your brain or spine, has not been successfully treated and is causing you problems
- Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or prostate
cancer in situthat was successfully treated at least 2 years ago
- Are unable to swallow or absorb tablets
- Are taking medication to thin your blood
- Are having fits
- Have had certain heart problems in the last 12 months
- Have had a blot clot or deep vein thrombosis (DVT) in the last 6 months
- Are HIV positive
- Are taking certain medicines - your doctor will discuss this with you
- Are pregnant or breastfeeding
This trial will recruit 99 people from the UK. Everyone taking part takes axitinib tablets daily. You take axitinib for as long as your doctor feels it is helping you.
If you agree to take part in this study, the researchers will ask for tissue samples (
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- CT scan
- Having a sample of tissue taken (
- Urine tests
Depending on where you have your treatment, you may need to go to a different hospital to have a biopsy - the trial doctor will explain if this will be necessary and if so, where you would need to travel to.
You see the doctor and have blood and urine tests frequently while you are having treatment.
When you stop treatment you see the doctors and have blood and urine tests.
You have CT scans every 8 weeks for 6 months then every 3 months until your cancer starts to grow again.
When you stop treatment the doctors will see you every 3 months to see how you are.
Axitinib is a new drug and there may be some side effects we do not know about. The side effects reported so far include
- Tiredness (fatigue)
- Raised blood pressure
- Feeling or being sick
- Loss of appetite
- Voice changes
- Shortness of breath
- Weight loss
- Painful joints
- Sore mouth
- Sore and peeling skin on your hands and feet
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
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.
Dr James Larkin
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
This is Cancer Research UK trial number CRUKE/11/061.