"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of cabozantinib after chemotherapy for sarcoma of the womb that has spread or can’t be removed with an operation (HGUtS study)
Coronavirus and cancer
We know it’s a worrying time for people with cancer, we have information to help. If you have symptoms of cancer contact your doctor.
This trial is for women with rare types 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. 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).
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 1 of the following types of sarcoma of the womb:
- High grade undifferentiated sarcoma of the womb
- High grade endometrial stromal sarcoma
- High grade leoimyosarcoma
- High grade adenosarcoma
And 1 of the following applies:
- your cancer has grown outside the womb into surrounding tissues (is locally advanced) or into nearby pelvic organs (stage 2 or stage 3) and you are going to have surgery followed by chemotherapy
- your cancer has spread to the bladder, back passage (rectum) or elswehere in the body (stage 4) and you are going to have chemotherapy
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
- Are at least 18 years old
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 any other types of sarcomas such as low grade endometrial stromal sarcoma, low grade or medium grade leiomyosarcoma, carcinosarcoma, low grade adenosarcoma, rhabdomyosarcoma or PNET of the womb or cervix
- Can’t have cabozantinib for any reason
- Have had cabozanitinib in the past
- Have had radiotherapy to areas of cancer spread to the bone in the last 2 weeks, you have had treatment with radionuclides within 6 weeks of starting trial treatment or you have ongoing side effects from radiotherapy
- Still have side effects from past treatments unless they are mild
- 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 a heart condition called QTc prolongation
- 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
- Are taking medication to thin your blood such as warfarin or clopidogrel
- 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 a digestive problem and are at high risk of developing a hole in the stomach or intestines, for example, you have cancer that has spread to your digestive system, a stomach ulcer or inflammatory bowel disease
- Have cancer that has spread to your digestive system or you develop a stomach ulcer in the month before starting trial treatment
- Have had a bleed in your lung in the last 3 months, a bleed in your stomach or intestines in the last 6 months or any other active bleeding problem
- Have any problem with your digestive system that would affect how you absorb the drug
- Have had minor surgery such as a tooth taken out within 28 days of starting trial treatment
- Have poor mouth hygiene or you have had major dental work within 28 days of starting trial treatment
- Hve had major surgery or a bad injury in the last 12 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 had any other cancer in the past 5 years unless it was very early stage and it has been sucessfully treated
- 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
This is a phase 2 trial. The researchers need 90 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)
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.
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy.
They might also ask to take 4 extra blood tests as part of this trial to look for biomarkers. 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.
You see trial doctors and have some tests before you start treatment. These include
- A physical examination
- Blood tests
- Heart trace (ECG)
- Heart scan (echocardiogram) or MUGA scan
- 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.
The most common side effects of cabozantinib include
- feeling or being sick
- a sore mouth
- changes in your voice
- tiredness (fatigue)
- sore and peeling skin on the palms of your hands or soles of your feet (hand-foot syndrome)
- numbness or tingling in your hands or feet (peripheral neuropathy) or difficulty walking
- taste changes
- loss of appetite
- high blood pressure
- weight loss
- changes in blood tests that measure how the thyroid and liver are working
There is a very small risk that cabozanitinib can cause
- holes in the stomach or intestines
- holes between 2 organs, for example the windpipe and food pipe (this is called a fistula)
The trial doctor will keep a close eye on you and treat any problems straight away.
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.
How to join a clinical trial
Dr Helen Hatcher
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)
International Rare Cancer Initiative (IRCI)
NHS Greater Glasgow and Clyde
This is Cancer Research UK trial number CRUK/13/020.