A trial looking at cediranib and olaparib for women with womb cancer (COPELIA)

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

Cancer type:

Secondary cancers

Womb (uterine or endometrial) cancer

Status:

Closed

Phase:

Phase 2

This trial is for women with womb cancer that has come back or spread to other parts of the body (advanced cancer). Womb cancer is also called uterine or endometrial cancer.

It is for women who have had treatment with chemotherapy that included a platinum drug in the last year.

More about this trial

Treatment for advanced womb cancer can reduce symptoms and help you feel better.

A combination of chemotherapy drugs such as paclitaxel and carboplatin (PC) is a common treatment. But after some time, the cancer may start to grow again. You usually have more treatment with paclitaxel if this happens.

Doctors are looking for ways to help women in this situation. In this trial, they are looking at cediranib and olaparib.

Cediranib is a cancer drug that stops cancer cells from growing new blood vessels.

Olaparib is a PARP inhibitor. It blocks a protein called PARP, which helps damaged cells to repair themselves. Olaparib is already a possible treatment for women with ovarian cancer.

Everyone taking part in this trial has 1 of the following:

paclitaxel (the standard treatment)
paclitaxel and cediranib
cediranib and olaparib

The main aim of this trial is to find out whether cediranib and paclitaxel or olaparib helps women with advanced womb cancer.

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.

Who can take part
You may be able to join this trial if all of the following apply:

you have womb (endometrial) cancer
your cancer continued to grow or spread to other parts of the body after treatment with a platinum chemotherapy that you had in the past year
you have at least 1 area of cancer that can be seen and measured on a scan
you have satisfactory blood tests results
your liver, heart and kidneys are working well
your thyroid is working well
you can swallow and absorb tablets
you are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
you are at least 16 years old
you are willing to stop eating grapefruit or grapefruit juice during treatment and for a month afterwards
are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility you could become pregnant

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related
You:

have cancer spread to the brain that this isn’t controlled
have moderate or severe side effects from previous chemotherapy, apart from hair loss
have had chemotherapy, radiotherapy, surgery or a tumour embolisation in the last month
are currently having cancer treatment
have had olaparib, cediranib or any other similar drug
have, or your doctor thinks you may have, acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
have had another cancer in the past 5 years apart from carcinoma in situ of the cervix and breast, basal or squamous cell skin cancer or any other cancer that has been successfully treated

Medical conditions
You:

have had an experimental treatment in the past month
have fits (seizures) that aren’t controlled
have an infection that isn’t controlled
have high levels of protein in your urine
take herbal supplements and you can’t stop them during treatment and for a month afterwards
have taken drugs that affect enzymes called CYP3A in the past 2 to 5 weeks (your doctor can tell you more about this)
have bowel problems such as a blockage (obstruction) or an abnormal passage (fistula) in the bowel or between the bowel and other organs
have heart problems such as hypertension that isn’t controlled, an abnormal heart rhythm (arrhythmia) or you have had a heart attack in the past 3 months
have HIV
have hepatitis B or hepatitis C
have had a bone marrow transplant from a donor (allogenic bone marrow transplant)
have any other serious medical problem or mental health condition that doctors think could affect you taking part

Other
You:

are pregnant or breastfeeding
are sensitive to paclitaxel, olaparib, cediranib or anything they contain

Trial design

This is a phase 2 trial. Researchers hope that around 129 women from the UK will agree to take part.

It is a randomised trial. The women taking part are put into 1 of the following treatment groups by a computer:

paclitaxel (group 1)
paclitaxel and cediranib (group 2)
cediranib and olaparib (group 3)

Neither you nor your doctor can choose which group you are in.

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Paclitaxel
You have paclitaxel as a drip into a vein (intravenously). You have it every week, for 3 weeks. After this you have a break of a week. And then have another 3 weeks of paclitaxel. This continues for as long as it is helping you and the side effects aren’t too bad.

It takes about an hour to have paclitaxel.

Paclitaxel and cediranib
You have paclitaxel in the same way as group 1. And you have cediranib as tablets that you swallow whole, every day.

You continue to have paclitaxel and cediranib for as long as the cancer doesn’t get worse and the side effects aren’t too bad. It can be for up to 6 months.

After 6 months, you may be able to continue to take cediranib alone.

Cediranib and olaparib
You have cediranib and olaparib as tablets that you swallow whole. You take:

cediranib every day
olaparib twice a day

This continues for as long as the cancer doesn’t get worse and the side effects aren’t too bad.

Blood tests
You have extra blood tests as part of this trial. Doctors want to find out more about how cediranib and olaparib work. You have the extra blood tests before the start of treatment and at set times during the trial.

You do not need to agree to have the extra blood tests if you don’t want to. You can still take part in this trial.

Tissue sample
Doctors will ask some women who join group 3 to give a tissue sample (biopsy) before the start of treatment. Researchers want to look at the DNA to see why some women are more likely to get womb cancer than others.

Only certain hospitals are helping with this part of the research. Your doctor can tell you more about this.

You do not have to agree to have a biopsy if you don’t want to. You can still take part in this trial.

Hospital visits

You see a doctor and have some tests before taking part. The tests might include:

a physical examination
blood tests
CT scan
heart trace (ECG)

During treatment, you see the trial team 3 times a month if you join group 1 or group 2. You see them every 2 weeks if you join group 3. You have blood tests and a physical examination each time you see them.

You have a CT scan every 6 weeks, for 3 months. You then have a CT scan every 12 weeks.

The trial team will give you a diary to complete at home. They will ask you to keep a record of when you take your tablets. You bring the diary with you to every trial visit.

When you finish treatment, you see the trial team after a month. You then continue to see your doctor as part of your normal follow up.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of paclitaxel are:

a drop in the number of blood cells increasing your risk of infection, tiredness and breathlessness and bleeding
numbness or tingling in fingers and toes
pain in your joints and muscles
tiredness (fatigue) during and after treatment
feeling or being sick
hair loss
low blood pressure
mouth sores
diarrhoea

The most common side effects of cediranib are:

high blood pressure
diarrhoea
feeling or being sick
muscle pain
heart, thyroid and kidney problems
an increased risk of bleeding
tiredness (fatigue) during and after treatment
sore mouth and a hoarse voice

The most common side effects of olaparib are:

a drop in the number of blood cells increasing your risk of infection, tiredness and breathlessness
cough
diarrhoea
tiredness (fatigue) during and after treatment and dizziness
feeling or being sick and indigestion
loss of appetite and taste changes
headaches
kidney problems

We have more information about the possible side effects of paclitaxel and olaparib.