A study looking at using everolimus for advanced kidney cancer

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

Cancer type:

Kidney cancer
Renal cell carcinoma




Phase 2

This is a study looking at using everolimus (also called Afinitor) for kidney cancer that has spread to another part of the body. It is open to people who are having surgery to remove the kidney as part of their treatment. This trial is supported by Cancer Research UK.

More about this trial

Doctors can treat advanced kidney cancer with surgery or biological therapy.

Everolimus is a biological therapy that doctors use for advanced kidney cancer that has come back either during or after treatment. It works by stopping a protein called mTOR from working properly and so may stop the cancer from growing or slow it down.

The researchers think that using everolimus before surgery may help people with advanced kidney cancer.

The aims of this study are to find out

  • How safe it is to give everolimus to people before and after having surgery to remove the kidney
  • What the side effects are
  • How well everolimus works after surgery for people with advanced kidney cancer
  • How the cancer changes before and after surgery

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 Open a glossary item)
  • CT scan
  • MRI scan
  • A biopsy Open a glossary item

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

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 in our treatment section.

Recruitment start:

Recruitment end:

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.

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

Chief Investigator

Dr James Larkin

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUKE/10/047.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6977

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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