A trial looking at pazopanib and sunitinib for advanced kidney cancer (PISCES)

Please note this trial is no longer recruiting patients.

This trial is comparing pazopanib with sunitinib as treatment for the most common type of kidney cancer called renal cell cancer. It is for people who have not yet had any treatment for kidney cancer that has spread (advanced kidney cancer).

Doctors often use biological therapy to treat advanced kidney cancer. One of the drugs they can use is called sunitinib.

This trial is comparing sunitinib with another drug called pazopanib. Both sunitinib and pazopanib are drugs called tyrosine kinase inhibitors (TKIs). TKIs block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

Researchers want to see if one drug causes fewer side effects than the other. In this trial, they will do this by asking people if they would prefer to carry on taking one drug rather than the other. It is called a ‘patient preference study’

Recruitment

Start 26/05/2010

End 20/04/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have renal cell cancer that is locally advanced or has spread to other parts of your body
Have satisfactory blood test results
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Can swallow tablets
Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to your brain, unless it has been treated and there has been no sign of it growing again for at least 6 months, it does not cause symptoms and you don’t need to take steroids or medicine to prevent fits
Have cancer that has spread to your airways or is growing into major blood vessels in your lungs
Can have surgery or radiotherapy to treat your cancer
Have had any treatment that reaches the whole body (systemic treatment) for advanced kidney cancer - you can take part if you had a cancer vaccine to try to stop kidney cancer coming back after you had surgery to remove it
Have had radiotherapy or treatment to block blood vessels supplying the kidney (embolisation) in the last 2 weeks
Have had major surgery or an injury in the last 4 weeks, or earlier if you have a wound that isn’t healing up or a broken bone that hasn’t mended
Have had an experimental drug as part of another trial in the last 4 weeks, or longer if some of the drug could still be in your body
Have had another type of cancer apart from non melanoma skin cancer that has been completely removed, carcinoma in situ that has been successfully treated, or any other type of cancer if you have been free of disease for 3 years
Have any problems with your digestive system that could put you at risk of bleeding into your gut or that affects how you absorb tablets
Have had a stroke, heart attack, heart pain (angina) or heart surgery in the last 6 months, or you have other heart problems that are a cause for concern – the trial doctors can advise you about this
Have bleeding problems, or have coughed up blood in the last 6 weeks
Have had a blood clot in the last 6 months – you can take part if you had a deep vein thrombosis that has been treated with blood thinning drugs (anticoagulants) for at least 6 weeks
Have high blood pressure that cannot be controlled with medication
Have an infection that cannot be controlled with medication or any other serious medical condition that the trial doctors think could affect you taking part
Are known to be sensitive to drugs that are similar to pazopanib or sunitinib
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit about 160 people in the UK and other countries. 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 you will not know which group you are in. This is called a double blind trial.

People in group 1 have pazopanib for 10 weeks, followed by 2 weeks without treatment. Then they have sunitinib for 10 weeks
People in group 2 have sunitinib for 10 weeks followed by 2 weeks without treatment. Then they have pazopanib for 10 weeks

So both groups have the same drugs but in a different order. Both drugs are tablets that you take every day. You won’t know which order you are taking them in.

If you stop treatment in the first 10 weeks because you have bad side effects or your cancer gets worse, you can switch to the other drug after a break of 2 weeks.

You have a number of blood tests during the trial. The researchers use some of the blood samples to learn more about what happens to the drugs in the body. They will also try to find biomarkers. These are substances in the body that doctors can measure to help them see how a disease is developing or a treatment is working.

The researchers will ask your permission to take some extra blood samples. They will use these samples to learn more about how genes affect the way people respond to a drug and the side effects they have. This is called ‘pharmacogenetics’. If you don’t want to give these extra samples for research, you don’t have to. You can still take part in the main trial.

After you have had both drugs, the researchers will ask you which one you would prefer to carry on taking. They will ask you this, before you find out which order you took the drugs in.

If the drug you preferred was pazopanib and the doctors can see that you need to have more treatment, you may be able to carry on having pazopanib as part of the trial. As long as you don’t have bad side effects, you can carry on having it until your cancer gets worse. You will have blood tests every 8 weeks and an ECG every 4 months. The trial doctors will decide how often you need to have scans.

If the drug you preferred was sunitinib, the trial doctors will talk to you about having this drug outside of the trial.

Hospital visits

You will see the trial doctors and have some tests before starting treatment. The tests include

Physical examination
Heart trace (ECG)
Blood tests
CT scan or MRI scan
Heart ultrasound (echocardiogram) or MUGA scan

During treatment, you go to hospital every 2 to 4 weeks. Each visit will last 1 to 2 hours. You have a blood test at each visit and an ECG at some visits. You will have a CT scan or MRI scan after 11 weeks and 20 weeks of treatment.

The trial team will ask you to fill out a number of questionnaires during the treatment. They will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study. You can complete the questionnaires by phone. It should take about 10 minutes each time.

Side effects

As pazopanib is quite a new drug, there may be some side effects that we don’t about yet. The side effects that are known include

Diarrhoea or constipation
Feeling or being sick
Stomach pain
Taste changes, loss of appetite or weight loss
Lightening of hair or skin colour
High blood pressure
Headache
Shortness of breath

The side effects of sunitinib include

Diarrhoea or constipation
Feeling or being sick
Stomach pain or upset stomach
Feeling tired or weak (fatigue)
Bleeding problems such as nosebleeds
Sore mouth
High blood pressure
Taste changes, loss of appetite or weight loss
Rash or blisters on your hands and feet
Dry or yellow skin
Lightening of hair or skin colour

There is more information about pazopanib and sunitinib on CancerHelp UK.

Both pazopanib and sunitinib can cause liver damage. During this study, you have blood tests to see how well your liver is working (liver function tests).

You must not take certain drugs or eat certain foods such as grapefruit during the trial, because they can affect how the drugs work. The trial doctors will tell you more about this.