Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at RAD001 for kidney cancer that has spread - RAPTOR
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at RAD001 (also called everolimus and Afinitor) for kidney cancer that has spread to other parts of the body.
Everolimus is a type of treatment called a biological therapy. It works by blocking the action of a protein called mTOR. The mTOR protein controls other proteins that cancer cells need in order to grow. The researchers hope this will help to stop or slow the growth of the cancer.
We know from research that everolimus has helped people with other types of cancer. The researchers think it may also help people with advanced kidney cancer.
The aims of this trial are to find out
- If everolimus can help people with advanced kidney cancer
- How safe it is to give everolimus to people with advanced kidney cancer
Who can enter
You can enter this trial if you
- Have a type of kidney cancer called papillary renal cell cancer type 1 or 2 that has spread
- Have at least 1 tumour that can be measured on a scan
- 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
- Your cancer has spread to your spinal cord or brain (central nervous system) and your symptoms are not controlled
- You have had radiotherapy in the last 4 weeks
- You have had radiotherapy to control bone pain in the last 2 weeks
- You have already had treatment that reaches the whole body (systemic treatment) for renal cell cancer that has spread, such as sunitinib, sorafenib or bevacizumab
- You have had everolimus, or similar drugs such as temsirolimus, before
- You are allergic to everolimus, or similar drugs, and their ingredients
- You are taking 10mg or more of steroid tablets daily (please note, it is important that you do not stop taking steroids unless your doctor tells you to)
- You have had another drug as a part of a clinical trial in the last 4 weeks
- You have had another cancer in the last 3 years, apart from non melanoma skin cancer or carcinoma in situ of the cervix
- You have heart problems or had a heart attack in the last 6 months
- You have liver problems
- You have serious breathing problems
- You have diabetes that is not controlled with medication
- You have an infection
- You have bleeding problems
- You are known to be HIV positive
- You have another serious medical condition that could affect you taking part in the trial
This is an international phase 2 trial. It will recruit 12 people in the UK. Everyone taking part in this trial will have everolimus.
Everolimus is a tablet. You take 2 tablets once a day at the same time each day. You take them on an empty stomach or with a light, low fat meal such as cereal with fat free milk, toast or bagel with a fat free spread.
Exactly how long you have treatment for, will depend on your side effects and whether the treatment is still helping to control your cancer.
You cannot eat certain fruits, or drink their juice, while having everolimus. This is because they can interfere with the way it works in your body. These fruits include grapefruit, Seville oranges and star fruit.
You will see the doctor and have some tests before you start treatment. These tests include
- Physical examination
- Heart trace (
- Blood tests
- CT scan or MRI scan
- Bone scan
- Urine test
- Chest X-ray
- Breathing test (
Lung function test) – if needed
- Pregnancy test (if appropriate)
You see the doctor
- Every 2 weeks for 3 months
- Every month for up to 2 years
Every 8 weeks you have a CT scan or MRI scan.
The most common side effects of everolimus are
- A drop in blood cells causing an increased risk of infection, bruising and bleeding problems
- Feeling or being sick
- Mouth ulcers
- Swelling of the lining of the mouth
- Rash or dry, itchy skin
- Loss of strength
- Loss of appetite
- Swelling of hands and feet
- Liver changes
- Weight loss
You can find more about everolimus on CancerHelp UK.
How to join a clinical trial
Dr Paul Nathan
Experimental Cancer Medicine Centre (ECMC)