"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of pazopanib after surgery to remove kidney cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
If kidney cancer hasn’t spread to another part of the body, it is possible to remove it with surgery. Even if your surgeon is able to remove the cancer completely, some cancer cells may remain in your body. These can travel to another part of your body and start growing there months or years later. Researchers want to know if having treatment after surgery can help to stop this happening. In this trial, they are looking at a drug called pazopanib.
Pazopanib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Doctors already use pazopanib to treat advanced kidney cancer. But in this trial, researchers want to see if it can help people who have kidney cancer that has been removed with surgery.
The aims of the trial are to
- See if having pazopanib after surgery can stop renal cell cancer coming back or delay its return and help people stay free of cancer for longer
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have renal cell cancer that is mostly clear cell type, has been completely removed with surgery and has not spread to other parts of your body (you will have a scan to check there are no signs of any cancer remaining)
- Have had surgery in the last 12 weeks and have fully recovered
- Have satisfactory blood test results
- Are able to carry on with life as normal (Karnofsky performance status of at least 80)
- Are at least 18 years old
- Are willing to use reliable contraception during the trial if there is any chance you could become pregnant
You cannot enter this trial if you
- Are having any other cancer treatment, or had any before or after surgery
- Have had any other type of cancer
- Have problems with your
digestive system, including (but not limited to) peptic ulcer, inflammatory bowel disease, an abnormal opening in the bowel called a fistula, or diarrhoea
- Have an infection that can’t be controlled with medication
- Have had a stroke or heart attack in the last 6 months, or have certain other heart problems – the trial team can advise you about this
- Have high blood pressure that can’t be controlled with medication
- Have problems with bleeding or your blood not clotting
- Have had another experimental drug in the last 30 days (or longer if there is any chance some of the drug could still be in your body)
- Have had another type of biological therapy that works in a similar way to pazopanib – the trial team can advise you about this
- Are known to be very sensitive to any drug similar to pazopanib
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Have HIV, hepatitis B or hepatitis C
- Are pregnant or breastfeeding
This phase 3 trial will recruit about 1,500 people from across the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
Half the people taking part have pazopanib tablets, the other half have dummy tablets (
You take the tablets each day for a year. You have to take them at least an hour before eating, or more than 2 hours afterwards.
You see the trial team and have some tests before you start treatment. The tests include
The trial team will also get a sample of the cancer that was removed when you had surgery. They will use this tissue sample and a blood sample to look for genes and proteins. This may help researchers to understand more about renal cell cancer, how pazopanib works in your body and which people may be most likely to benefit from the drug in the future.
You see the trial team 5 times in the first 8 weeks of treatment, once every 4 weeks from then until the end of 7 months, and then once every 8 weeks until the end of the year.
You have a physical examination and blood tests at each visit. At 3 of the visits, you have another heart trace.
The trial team will ask you to fill out a questionnaire before you start treatment, 4 times during the year and when you finish treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You have 3 CT or MRI scans during the year – you have these scans even if you stop the trial treatment.
When you finish treatment you have a physical examination, blood tests and a heart trace. You then see the trial team once every 6 months for up to 4 years and once a year after that. You have a physical examination, blood tests and a CT or MRI scan each time.
The most common side effects of pazopanib include
- Feeling or being sick
- Tummy (abdominal) pain
- Loss of appetite
- Hair or skin colour changes
- Changes to the way your liver works
- High blood pressure
- Weight loss
- Rash or blisters on the palms of your hands or soles of your feet
- Taste changes
- Sore mouth
- Cough or difficulty breathing
- Rash and peeling skin
- Muscle or joint pain
- Swelling caused by a build up of fluid in your face, hands, feet or ankles
- Slow heart beat
- Changes to the level of sugar in your blood
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.
Experimental Cancer Medicine Centre (ECMC)