A study looking at using everolimus for advanced kidney cancer

Who can enter

You can enter this trial if you

• Have kidney cancer that has spread to another part of your body
• Have a least one area of cancer outside the kidney that can be measured on a scan
• Are to have your kidney removed as part of your treatment
• Have satisfactory blood test results
• Are fully active and able to look after yourself, apart from doing heavy physical work (performance status 0, 1)
• Are willing to use reliable contraception if there is a chance that 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 (you may be able to join if a scan shows that this spread has been stable for 6 months or more OR if you had surgery to remove a single area of cancer spread at least 3 months ago and the disease is no worse)
• Need to have your kidney removed urgently or to relieve symptoms caused by the cancer
• Have had steroids in the last 28 days – you must not stop taking these medications without talking to your doctor
• Have had another cancer in the last 5 years – you may join the trial if you have basal cell or squamous cell skin cancer and in situ carcinoma of the cervix that has been successfully treated
• Are known to be HIV positive
• Have another serious medical condition that could affect you taking part in the trial
• Are pregnant or breastfeeding

Trial design

This is a phase 2 study. It will recruit 40 people.

Everyone will have everolimus for 6 weeks before surgery to remove their kidney. You stop taking it one week before surgery. You start talking it again when you have recovered from surgery, about 2 to 3 weeks after your operation. Your doctor will tell you when to start taking it again.

You continue to have everolimus as long as the doctors think it is helping to control your cancer.

You take everolimus as a tablet once a day. You should try to take it at the same time each day and swallow it whole with a glass of water. You can take it with or without food.

If you agree to take part in this study, the researchers will ask your permission to take a small piece of tissue (biopsy) from your cancer. This will be before you have surgery. They will take it from your kidney and part of the body where your cancer has spread.

Hospital visits

You will see the doctor and have a number of tests before taking part in this study. These tests include

• A physical examination
• Blood test
• Urine test
• Breathing tests (lung function tests)
• CT scan
• MRI scan
• A biopsy

Before surgery you see the doctor during the 4th and 6th weeks of your treatment with everolimus. You have the following tests

• A physical examination
• Blood test
• Breathing test
• CT scan
• MRI scan

After your operation, when you have started taking everolimus again, you see the doctor every 4 weeks and have the following tests

• A physical examination
• Blood test
• Breathing test – if needed
• CT scan – then every second visit

You have another MRI scan and biopsy if your cancer starts to grow again.

Side effects

The side effects of everolimus can include

• Tiredness
• A change in taste
• Swelling of the lining of the mouth
• Rash
• A drop in blood cells causing an increased risk of infection, bruising or bleeding
• Feeling, or being, sick
• Loss of appetite
• Constipation
• Shortness of breath

You cannot eat certain fruits, or drink their juice, while having everolimus. This is because they can interfere with the way the drug works in your body.

You can find more information about everolimus on CancerHelp UK.