A trial looking at axitinib for advanced soft tissue sarcoma - Axi-STS

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

Cancer type:

Sarcoma
Soft tissue sarcoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called axitinib. It is for soft tissue sarcomas including

The people taking part have sarcoma that has spread to the lymph nodes (is locally advanced) or to any other organs of the body. This trial is supported by Cancer Research UK.

Doctors often treat soft tissue sarcomas with surgery, radiotherapy, chemotherapy, or a combination of these. But sometimes when soft tissue sarcoma has spread, doctors are not able to use surgery or radiotherapy. They may use chemotherapy but it does not always work. So doctors are always looking for new treatments to help people with advanced soft tissue sarcomas.

Axitinib is a new type of biological therapy called a tyrosine kinase inhibitor (TKI for short). It works by blocking the growth of new blood vessels. Cancer cells need their own blood vessels to get the food and oxygen in order to grow and multiply. If growth of new blood vessels is blocked, cancer cells may starve and die.

The aims of this trial are to find out

  • If axitinib can help people with advanced soft tissue sarcoma
  • How safe and acceptable axitinib is for people with advanced soft tissue sarcoma

Who can enter

You can enter this trial if you

  • Have a soft tissue sarcoma that has spread to your lymph nodes or to another part of your body (stage 4)
  • Have a soft tissue sarcoma that cannot be successfully treated with surgery or radiotherapy
  • Have a soft tissue sarcoma that can be measured on a scan
  • Have a soft tissue sarcoma that has continued to grow in the last 6 months and you have not had any treatment for it since it started to grow again
  • Have satisfactory blood test results
  • Have satisfactory urine test result
  • Have a negative pregnancy test (if applicable)
  • Are willing to use reliable contraception while taking part in the trial, and for 4 weeks afterwards, if there is a chance that you or your partner could become pregnant
  • Are able to look after yourself and are up and about for at least half the day (performance status 0, 1, 2)
  • Are at least 16 years old

You cannot enter this trial if you

  • Have a sarcoma that is an osteosarcoma, Ewing’s/PNET sarcoma, chondrosarcoma, gastrointestinal stromal tumour (GIST), dermatofibrosarcoma protuberans (DFSP), malignant mesothelioma or mixed mesodermal tumour of the uterus
  • Are able, and willing, to have chemotherapy to treat your cancer
  • Have had more than 2 courses of treatment with chemotherapy
  • Have had treatment for your cancer in the last 4 weeks and have not fully recovered
  • Have sarcoma that has spread to your brain or spine (central nervous system)
  • Have sarcoma that has spread to your lungs and is creating small pockets (cavities) in the lung
  • Have sarcoma that has spread and a scan shows that it is close to, or growing into, a major blood vessel Open a glossary item of the lung
  • Are taking medicine that affects the CYP3A4 or CYP1A2 enzymes (your doctor can advise about this)
  • Have had a problem with bleeding or blood clotting in the past year
  • Are taking a blood thinning medicine called warfarin
  • Have had another cancer in the last 3 years, except for non melanoma skin cancer that has been successfully treated or carcinoma in situ Open a glossary item of the cervix or breast
  • Have a serious heart condition or have had heart problems in the last year
  • Have high blood pressure that cannot be controlled
  • Have coughed up blood clots in your sputum for more than 2 weeks or on more than 3 separate occasions in the last 6 months
  • Have problems with your gut that could affect the amount of the trial drug you are able to take in (your doctor can advise about this)
  • Have another serious medical condition that could affect you taking part in the trial

Trial design

This is a phase 2 trial. It will recruit between 72 and 152 people from major sarcoma centres in the UK. There are 4 different groups in this trial. They are people who have

Everyone taking part will have axitinib. Axitinib is a tablet. You take it twice a day (12 hours apart). You can take axitinib for up to 2 years unless your cancer starts to grow again or the side effects become too much.

If you have a very bad side effect as soon as you start taking axitinib, your doctor may tell you to stop taking it for a period of 2 weeks. If the side effect gets better after 2 weeks, your doctor may start you on a lower dose of axitinib.

While taking axitinib you should not drink grapefruit juice or take certain medications. These include blood thinning medications such as aspirin and warfarin, and painkillers such as ibuprofen, naproxen and diclofenac.  This is because these can interfere with the way axitinib works. Your doctor will advise you more about this.

Axitinib can affect your blood pressure Open a glossary item so you will need to measure your blood pressure at home each time before taking your tablets. Your doctor will give you a machine to do this and explain how to take your blood pressure yourself. You will have a diary to write down your blood pressure each time you take it. You need to bring this in with you when you see the doctor.

If you agree to take part in the trial and the cancer is on your skin, the researchers will ask your permission to photograph it. The photograph will only be of the area where the cancer is. They will take the photographs before you start treatment, at regular times during your treatment and after you have finished treatment.

If you agree to take part in the trial, the researchers will ask permission for some blood samples and tissue sample from when you had your biopsy or surgery.

If you have angiosarcoma you may need to have another biopsy done for the researchers to get the tissue sample. You can choose whether you want to have this done, or not. Your choice will not affect you taking part in the trial.

These samples will have all your personal details removed and be kept at the University of Sheffield to help with further research into soft tissue sarcomas.

Hospital visits

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

  • Physical examination
  • CT scan or MRI scan
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Chest X-ray
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • Urine test
  • Photograph of the cancer on your skin (if applicable)
  • Pregnancy test (if applicable)

During treatment you see the doctor every 4 weeks and have the following tests

  • Physical examination
  • Blood tests
  • Chest X-ray (at week 4, 8 and 12 then every 12 weeks)
  • CT scan or MRI scan (every 12 weeks)
  • Photograph of the cancer on your skin (every 12 weeks – if applicable)

When you finish your treatment you see the doctor and have the following tests

  • Physical examination
  • Blood tests
  • Chest X-ray
  • CT scan or MRI scan
  • Photograph of the cancer on your skin (if applicable)

After treatment you see the doctor every 12 weeks and have a CT scan or MRI scan until your cancer starts to grow again.

Side effects

Axitinib is a new drug and there may be some side effects we do not know about. The side effects reported so far include

 

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

Prof Penella Woll

Supported by

Cancer Research UK
Cancer Research UK Clinical Trials Unit Birmingham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Pfizer
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield

Other information

This is Cancer Research UK trial number CRUK/09/009.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 3850

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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