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A trial of cediranib for alveolar soft part sarcoma (CASPS)

This trial is looking at a drug called cediranib to treat alveolar soft part sarcoma. This trial is supported by Cancer Research UK.

Alveolar soft part sarcoma (ASPS) is a rare type of soft tissue sarcoma. It usually affects the soft tissue of the leg, but can grow elsewhere. It mainly affects younger people. Doctors know that it is difficult to treat and may use chemotherapy and surgery but it doesn’t always work. You may have radiotherapy if the cancer is causing you a problem, such as pain. But, this does not always work very well. Doctors are looking for ways to improve treatment for ASPS and in this trial they are testing a drug called cediranib.

For a sarcoma to grow, it needs its own blood supply to develop. The growth of blood vessels is called angiogenesis. Cediranib is a new type of biological therapy. It blocks the cancer from developing its own blood supply and this may help to slow or stop cancer growth. It is called an anti angiogenic drug.

The aim of this study is to see if cediranib can help people with alveolar soft part sarcoma.

Recruitment

Start 11/05/2011
End 31/07/2016

Phase

Phase 2

Who can enter

You can enter this trial if you

  • Have alveolar soft part sarcoma (ASPS) that has got worse in the last 6 months
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have sarcoma that can be measured using a CT scan or MRI scan
  • Have satisfactory blood and urine test results
  • Are willing to use reliable contraception during the trial and for 2 weeks after treatment if there is any chance that you or your partner could become pregnant
  • Are at least 16 years old

You cannot enter this trial if you

  • Cannot swallow or absorb tablets for any reason
  • Have sarcoma that has spread to your brain, which has got worse in the last 6 weeks and needed an increase in medication to control symptoms
  • Have any severe medical problem, including infection
  • Have had severe problems with bleeding in the last 3 months
  • Have coughed up more than a teaspoon of blood in the last month
  • Have had major surgery in the last 2 weeks, or have a wound that has not healed
  • Have had treatment for your cancer in the last 4 weeks, unless it was radiotherapy to relieve symptoms (palliative radiotherapy)
  • Have had a recent blood clot
  • Have had any other cancer, apart from carcinoma in situ or non melanoma skin cancer that was successfully treated at least 5 years ago
  • Are pregnant or breastfeeding

Trial design

This international trial will recruit 36 people. It is a randomised trial. The people taking part are put into 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in either. This is called a double blind trial.

  • People in group 1 take cediranib tablets each day
  • People in group 2 take dummy tablets (placebo) each day

You take cediranib or placebo for 24 weeks. If your cancer starts to grow during the 24 weeks, the trial doctors will find out which group you are in. If you have been taking the dummy drug (placebo), then you will be able to start taking cediranib instead.

If your cancer has not grown after 24 weeks, you will find out whether you have been taking cediranib or placebo.

If you have been taking the placebo, you will be able to change to cediranib. If you have been taking cediranib you will continue this until your cancer starts to grow again.

Doctors would like to find out more about how cediranib affects alveolar soft part sarcoma (ASPS). To do this they would like to take biopsies of your cancer

  • Before you start treatment
  • 2 weeks later
  • When the cancer gets worse

They would also like to take blood samples for research. You give these before you start treatment, then 2, 4 and 8 weeks later. If you don’t want to give these extra samples for research, you don’t have to. You can still take part in the main trial.

Hospital visits

Before you start treatment you will see the trial doctors and have some tests. The tests include

  • Physical examination
  • Urine test
  • Blood test
  • CT scan
  • Heart trace (ECG)

For the first 4 weeks you will have your blood pressure checked weekly, this can be done at home or at your GP surgery.

You will visit the trial team 2 and 4 weeks after starting treatment, then every 4 weeks after that. At each visit you have a physical examination, an ECG and blood and urine tests.

You will have a CT scan every 8 weeks for the first year and then every 12 weeks until your cancer starts to grow again.

When your cancer starts to grow, you will stop cediranib. One month after stopping treatment you go back to see the trial doctors again.

Side effects

The most common side effects of cediranib are

Location of trial

  • Bristol
  • London
  • Manchester
  • Newcastle upon Tyne
  • Nottingham

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor Ian Judson

This is Cancer Research UK trial number CRUK/10/021.

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
National Institute for Health Research Cancer Research Network (NCRN)
The Royal Marsden NHS Foundation Trust
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Updated: 10 March 2014