A study of axitinib for kidney cancer (NAXIVA)

Cancer type:

Kidney cancer
Renal cell carcinoma

Status:

Open

Phase:

Phase 2

This study is looking at having axitinib before surgery for kidney cancer to help shrink the cancer or stop it growing. It is open to people who can have surgery to remove all, or part, of their cancer.

More about this trial

Axitinib (Inlyta) is a targeted cancer drug called a tyrosine inhibitor. It works by blocking certain proteins called tyrosine kinases that signal the cancer cell to grow.

Previous studies suggest that tyrosine inhibitors might slow, or stop the growth of cancers. It might also reduce the size of the cancer.

At the moment axitinib is used after surgery for kidney cancer that has spread to another part of the body. In this study researchers want to know if having axitinib before surgery can stop the cancer from growing or shrink the cancer. This could then reduce the amount of surgery you need to remove the kidney cancer.

Everyone in this study will take axitinib for a short time before their surgery.

The main aim of this study is see if axitinib can stop kidney cancer from growing or shrink it before having surgery.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

You may be able to join this study if all of the following apply. You:

  • have stage 3 kidney cancer
  • have a type of renal cell cancer called clear cell
  • are suitable for and willing to have surgery
  • have a urine dipstick test that shows there is less than 2+ of protein in your urine. If there is 2+ or more protein a 24 hour urine collection must show there is less than 2 grams of protein in your urine over the 24 hours or you have a blood test that shows the urinary protein creatnine ratio (PCR) is below a certain level
  • have satisfactory blood tests results
  • can do everything apart from heavy physical work (performance status 0 or 1)
  • are willing to use reliable contraception during treatment and a week afterwards for women and at least 6 months afterwards for men
  • are at least 18 years old

You cannot join this study if any of these apply.

Cancer related
You:

  • have cancer that has spread to more than 1 lymph node Open a glossary item
  • have cancer that has spread to another part of the body that is growing and hasn’t been treated, and you are suitable to have surgery to reduce the cancer and your doctor thinks there is a high risk your cancer might come back after surgery  
  • have another cancer apart from successfully treated non melanoma skin cancer Open a glossary item, in situ carcinoma  Open a glossary itemof the cervix, prostate cancer that is completely in the prostate that has been successfully treated with the aim to cure, is a low to moderate risk of coming back and your PSA isn't rising or your prostate cancer is stage T1 or T2a, your Gleason score is 6 and your PSA is 10 or lower and you haven't had treatment but are under active survelliance
  • have cancer that is causing pressure on your spinal cord (spinal cord compression Open a glossary item)
  • have cancer that has spread to the lining of your brain

Medical conditions
You:

  • have signs or symptoms of severe liver disease, endocrine Open a glossary item disease or lung disease that is getting worse or not controlled by medication
  • have liquid food through a drip into a vein (parental nutrition)
  • have had bleeding from your stomach or gut in the past 3 months that isn’t due to your cancer    
  • have had surgery to your stomach or gut that affects how well you absorb food and medication
  • have a disorder that affects how well your digestive system Open a glossary item absorbs food or medication
  • have a peptic ulcer that needed treatment in the past 6 months
  • have had a heart attack, heart failure or angina in the past 12 months
  • have had heart surgery called an artery bypass graft in the past 12 months
  • have had a stroke (CVA) or mini stroke (TIA) in the past 12 months
  • have fits (seizures)
  • have high blood pressure that isn’t controlled by medication
  • have HIV or AIDs
  • have very bad liver damage
  • are taking, or might need to take, medication that affects the CYP enzymes
  • are taking blood thinning medication, such as warfarin, that affects how vitamin K works in the body. You might be able to join the study if you are taking it to keep a central line open or to prevent a blood clot (DVT)

Other
You:

  • are very sensitive to axitinib or any of its ingredients. People with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not join the study
  • are pregnant or breastfeeding

Trial design

This is a phase 2 study. The study team need 20 people to join.

Everyone takes axitinib for 8 weeks before surgery. You have your surgery during week 9.

Axitinib is a tablet you take twice a day. Your doctor will tell you how many to take. After 2 weeks your doctor might increase your dose if you don’t have any bad side effects.

Samples
You have a sample of tissue (biopsy) done between 1 and 4 weeks before starting axitinib. This to find if you able to join the study.

At the same time the team will take 4 extra samples of tissue.

The team will also take an extra blood sample and urine sample:

  • before starting axitinib
  • every 2 weeks while taking axitinib
  • the week of your surgery
  • 12 weeks after surgery

They will use these samples and the tissue samples to:

  • find out more about kidney cancer
  • look for substances (biomarkers) that might show how well axitinib is working  

You don’t have to agree to give these extra samples. You can still take part in the main study.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

A week before starting treatment you see the doctor to have:

  • a physical examination
  • blood tests
  • urine test

You see the doctor every 2 weeks during treatment for the same tests.

Everyone has an MRI scan in the 3rd week. People whose cancer hasn’t spread will also have CT scan at this time.

Everyone has a CT scan in the week of surgery.

After surgery you see the doctor at 6 weeks and 12 weeks for:

  • a physical examination
  • blood tests
  • CT scan (at 12 weeks only)

Your doctor will then tell you how often they want to see you after this.

Side effects

The common side effects of axitinib are:

We have more information about axitinib.

Your doctor will talk to you about the side effects before you agree to take part in the study.

Location

Cambridge
Chelmsford
Edinburgh
Glasgow
London
Sutton

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

Mr Grant Stewart

Supported by

Common Services Agency (CSA)
NHS National Services Scotland
Pfizer
Scottish Clinical Trials Research Unit (SCTRU)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14833

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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