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.

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at RAD001 (also called everolimus and Afinitor) for kidney cancer that has spread to other parts of the body.

The most common type of kidney cancer in adults is renal cell cancer. This trial is for people who have a particular type of renal cell cancer called papillary renal cell cancer.

Doctors often treat kidney cancer with interferon and interleukin 2. But doctors are always looking for new ways to treat people with kidney cancer.

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

Trial design

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.

Hospital visits

You will see the doctor and have some tests before you start treatment. These tests include

Physical examination
Heart trace (ECG )
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.

Side effects

The most common side effects of everolimus are

A drop in blood cells causing an increased risk of infection, bruising and bleeding problems
Tiredness
Feeling or being sick
Mouth ulcers
Swelling of the lining of the mouth
Diarrhoea
Rash or dry, itchy skin
Loss of strength
Loss of appetite
Cough
Swelling of hands and feet
Liver changes
Headache
Weight loss
Infection