A trial comparing everolimus with sunitinib for kidney cancer that has spread - ASPEN

This trial is comparing everolimus (Afinitor) with sunitinib (Sutent) for kidney cancer that has spread. The most common type of kidney cancer is renal cell cancer. This trial is open to people with renal cell cancer apart from clear cell.

At the present time there is no standard treatment for kidney cancer that has spread. But some doctors might use sunitinib.

Sunitinib is a type of biological therapy called a tyrosine kinase inhibitor (TKI). 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.

Everolimus is a type of biological therapy called an mTOR inhibitor. It stops a particular protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. By blocking mTOR, everolimus helps to stop cancer growing.

Researchers want to compare sunitinib with everolimus to find out which is best to treat non clear cell kidney cancer that has spread.

The aims of this trial are to find out

How well everolimus and sunitinib works for kidney cancer that has spread
More about the side effects of these 2 drugs
How they affect quality of life

Recruitment

Start 01/05/2011

End 31/05/2014

Phase

Phase 2

Who can enter

You can enter this trial if you

Have a type of kidney cancer called renal cell cancer (apart from clear cell renal cell cancer)
Have kidney cancer that has spread to another part of the body
Have had a sample of tissue taken of your cancer
Have at least one area of cancer outside the kidney that can be measured on a scan
Have satisfactory blood test results
Can mostly take care of yourself (Karnofsky performance score 60 and above)
Are willing to use reliable contraception if there is a chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have a type of kidney cancer called clear cell
Have cancer that has spread to your brain or spinal cord unless it has been treated and the cancer has not grown in the past 6 weeks
Have already had treatment for kidney cancer that affects the whole body, such as chemotherapy
Have had radiotherapy, major surgery, a sample of tissue (biopsy) or an injury in the last 4 weeks
Have had any other cancer in the last 5 years apart from non melanoma skin cancer , carcinoma in situ of the cervix, prostate cancer that has not spread to another part of the body (stage T1, T2) or early bladder cancer (CIS, stage Ta, T1)
Are known to be sensitive to the ingredients of everolimus or sunitinib
Are not able to take medications to control allergies, such as anti histamines
Are not able to take medications to control inflammation
Are taking medication that affects the immune system or have had such medication in the last 4 weeks
Have had a live vaccine in the past week
Are on medication that strongly affects an enzyme called CYP3A4 – your doctor can advise you about this
Have an infection
Have a wound or ulcer that has not healed
Have had a major bleed in the last month
Have high blood pressure that is not controlled by medication
Have had a heart attack, congestive heart failure or angina in the last 6 months
Have had a blood clot in the lungs in the last 6 months
Have diabetes that is not controlled by medication
Have severe breathing problems
Have advanced liver disease such as cirrhosis
Have any other medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. It will recruit 108 people from different countries around the world. You will be put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in. This is called randomisation. You will have either everolimus or sunitinib. You will know which one you are taking.

Everolimus is a tablet. You take it once a day without food or with a light non fatty meal, such as toast and cereal. Each time you see the doctor, you take home enough tablets to last for 6 weeks.

Sunitinib is a capsule. You take it once a day, every morning, with or without food. Every time you see the doctor, you take home enough capsules for 4 weeks. You then have 2 weeks of not taking sunitinib.

Each 6 weeks is called a cycle of treatment. How long you have treatment depends on whether it is still helping or how bad the side effects are.

While taking part in this study you should not have grapefruit juice or anything with grapefruit in it. This is because it can interfere with your treatment.

You fill in a questionnaire before you start treatment and at the end of each cycle of treatment. It will ask how you are feeling and what activities you can do.

If you take part in this trial, the researchers will ask your permission to store your blood samples, and take samples of tissues from when you had a biopsy. Future researchers may use these to learn more about kidney cancer. You do not have to give these samples if you do not want to. You can still take part in the main trial.

Hospital visits

Before you start the trial, you will see the doctor and have some tests. These include

A physical examination
Blood tests
CT scan or MRI scan
Urine test
Bone scan

During treatment you see the doctor every 6 weeks for a physical examination, blood tests and urine test. Every 12 weeks you also have a CT scan and bone scan.