A trial of cabozantinib after chemotherapy for sarcoma of the womb that has spread or can’t be removed with an operation (HGUS study)

Cancer type:

Sarcoma
Soft tissue sarcoma
Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Phase 2

This trial is for women with a rare type of high grade sarcoma of the womb.

Cancer Research UK supports this trial.

More about this trial

Chemotherapy is used to treat sarcomas of the womb (uterine sarcomas). This helps but doctors are always looking for ways to improve treatment. In this trial they are looking at a drug called cabozantinib.

Cabozantinib is a type of biological therapy Open a glossary item. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. 

Researchers think that having cabozantinib after chemotherapy might delay or prevent the sarcoma from starting to grow again. This is called maintenance therapy.

In this trial, some women have cabozantinib after chemotherapy and some have a dummy drug (placebo Open a glossary item).

The aims of the trial are to

  • find out if cabozantinib maintenance therapy is useful for sarcomas of the womb
  • learn more about the side effects

Who can enter

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

You may be able to join the 1st part of the trial if

  • You have a high grade undifferentiated sarcoma of the womb that is newly diagnosed and has grown outside the womb into surrounding tissues (is locally advanced) or you had surgery for locally advanced cancer but it wasn’t possible to remove some areas of cancer OR your cancer has spread to another part of the body after treatment

As well as the above, the following must also apply. You

  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for 4 months afterwards if there is any chance that you could become pregnant

You may be able to join the 2nd part of the trial if all of the above apply and your cancer stays the same or shrinks after chemotherapy.

You cannot join this trial if any of these apply. You

  • Have a low grade extra skeletal Ewings sarcoma or a low grade leiomysarcoma Open a glossary item
  • Have any other types of sarcomas such as carcinosarcoma, adenosarcoma, rhabdomyosarcoma Open a glossary item or PNET Open a glossary item of the womb or cervix
  • Can’t have cabozantinib for any reason 
  • Have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart  failure (fluid around you heart) or severe peripheral vascular disease (restriction in the flow of blood to your legs), major surgery to the arteries around your heart, or a stent in your heart
  • Have had had a major stroke in the past or you have had a mini stroke (TIA) in the last 6 months
  • Have had a blood clot in your leg or lung in the last 6 months
  • Have a hole, a blockage or an abnormal opening called a fistula in your gut, tummy (abdomen) or vagina or a collection of pus in your tummy in the 6 months before joining the trial
  • Have areas of gas around a lesion in your lung
  • Have cancer that has grown into a major blood vessel
  • Have cancer that has spread to your digestive system or you develop a stomach ulcer in the month before starting trial treatment
  • Have any bleeding problem in the last 3 months
  • Have any problem with your digestive system that would affect how you absorb the drug
  • Have had major surgery or a bad injury in the last 6 weeks or a wound, fracture or ulcer that isn’t completely healed
  • Have taken any medication that blocks an enzyme called CYP3A4 in the 7 days before joining this trial
  • Can’t swallow tablets
  • Are going to have any other treatment for your cancer during the trial
  • Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 78 women to take part. 

The trial is in 2 parts. In part 1 you have chemotherapy. In part 2 you have cabozantinib or the dummy drug. 

In part 1, you have standard treatment with 2 chemotherapy drugs called doxorubicin and ifosfamide. Or you might have doxorubicin alone. If the chemotherapy helps, you may then be able to join the 2nd part of the trial. This is the maintenance part. 

If the chemotherapy doesn’t work and the cancer has continued to grow, your doctor will talk to you about other treatment options. 

Part 2 is randomised. You are put into treatment groups by a computer. Neither you nor your doctor can choose which group you are in. Neither of you will know which group you are in. This is called a double blind trial.

  • one group have cabozantinib
  • the other group have a dummy drug (placebo Open a glossary item)

HGUS study diagram

You have your chemotherapy once every 3 weeks. Each 3 week period is called a cycle of treatment. You have between 4 and 6 cycles.

Cabozantinib and the dummy drug are tablets. You take 1 tablet every day.

You continue with treatment for up to 2 years as long it is helping you and the side effects aren’t too bad. 

If your cancer gets worse and you are having the dummy drug, you might be able to start having cabozantinib instead. Your doctor can tell you more if this applies.

Research samples
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item

They might also ask to take 4 extra blood tests as part of this trial to look for biomarkers Open a glossary item. Where possible you have these at the same time as your routine blood tests. 

You don’t have to give these extra samples if you don’t want to. You can still take part in the trial.

Quality of life
The trial team will ask everybody taking part in the trial to complete some questionnaires before treatment starts and then regularly throughout treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.

Hospital visits

You see trial doctors and have some tests before you start treatment. These include

  • A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item) or MUGA scan Open a glossary item
  • CT scan and MRI scan

You have your chemotherapy at the hospital. You should not need to stay overnight.

If you join part 2, you go to hospital every 2 weeks. The doctor will examine you and may repeat some of the tests you had before you started treatment. After 2 months you go to hospital once a month for a check up.

You have a CT or MRI scan 

  • every 2 months in the 1st year of the trial
  • every 3 months in the 2nd year

When you finish treatment you see the trial team a month later. They will continue to follow you up every 6 months to see how you are getting on.

Side effects

The most common side effects of cabozantinib include 

  • diarrhoea or constipation
  • feeling or being sick
  • a sore mouth
  • tiredness (fatigue)
  • sore and peeling skin on the palms of your hands or soles of your feet soles of your feet (hand-foot syndrome)
  • numbness or tingling in your hands or feet (peripheral neuropathy) or difficulty walking
  • taste changes
  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • high blood pressure and some changes in the electrical activity of the heart
  • changes in blood tests that measure how the pancreas and liver are working

You mustn’t drink grapefruit juice during the trial as this can affect how cabozantinib works. You should also avoid having a herbal treatment for depression called St John’s Wort. The trial team will give you more information about this. 

We have information about doxorubicin and ifosfamide.

Location

Cambridge
Glasgow
London

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

Dr Helena Earl

Supported by

Cancer Research UK
Exelixis
Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)
International Rare Cancer Initiative (IRCI)
NHS Greater Glasgow and Clyde

 

Other information

This is Cancer Research UK trial number CRUK/13/020.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11734

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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