A trial of everolimus and a type of internal radiotherapy for neuroendocrine tumours (COMPETE)

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

Cancer type:

Carcinoid

Neuroendocrine tumour (NET)

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is for people with a neuroendocrine tumour (NET) that started in the pancreas or the gastrointestinal tract. The gastrointestinal tract includes the:

stomach
bowel

It is for people who have a NET that has spread to other parts of the body (metastatic) or that cannot be removed with surgery.

Everyone taking part has certain proteins on the surface of their cancer cells called somatostatin receptors.

More about this trial

Neuroendocrine tumours (NETs) are rare cancers that start in neuroendocrine cells. They often develop slowly over some years. Neuroendocrine cells are part of our neuroendocrine system. They make hormones that control how our bodies work.

Surgery is the main treatment for NETs. This is often the only treatment you need. But sometimes NETs can spread to other parts of the body, or your doctor may not be able to completely remove the cancer during surgery. You have other treatments such as targeted drugs if this happens.

Everolimus (Afinitor) is a type of targeted drug called a cancer growth blocker. It stops a protein called mTOR from working properly. Everolimus is already a possible treatment for people with advanced NETs. It can stop the cancer from growing for some time.

In this trial, doctors are looking at a type of internal radiotherapy called peptide receptor radionuclide therapy (PRRT). PRRT uses a radioactive substance (radiopharmaceutical) called 177 Lu-Edotreotide. Some neuroendocrine cells have proteins on the outside of them called somatostatin receptors. The hormone somatostatin attaches to this receptor and slows down the production of hormones by the cell.

By attaching the radioactive substance (Lu) to a man made form of the hormone somatostatin (the somatostatin analogue Edotreotide), the radiopharmaceutical can be given directly inside the neuroendocrine tumour cell. In this way, the cancer cell can be destroyed.

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

peptide receptor radionuclide therapy (PRRT) with 177 Lu-Edotreotide
standard treatment with everolimus

The main aim of this trial is to find out whether PRRT helps people with NETs that have spread to other parts of the body and cannot be removed with surgery.

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 a NET that started in the stomach, bowel or pancreas
your NET is likely to grow slowly (grade 1 or grade 2)
your cancer has spread to other parts of the body (metastatic) or doctors think they cannot remove the cancer completely with surgery
you are willing to have a sample of tissue taken (biopsy) if there isn’t a suitable sample available
you have at least 2 areas of cancer that can be seen and measured on a CT scan or an MRI scan
you have had a scan in the last 3 months
your cancer has proteins called somatostatin receptors on its surface (somatostatin receptor positive)
you are able to care for yourself but not able to carry on with all your activities or do active work (Karnofsky performance status of 70 or more)
your kidneys are working well
you have satisfactory blood tests results
you are at least 18 years old
you are willing to use reliable contraception during treatment and for around 2 months afterwards if there is any possibility that you or your partner could become pregnant

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

Cancer related

your NET has spread to the brain
you have a lot of cancer spread in the liver (more than 70%)
your NET makes hormones that go into the bloodstream (functioning NET). You can take part if you have a functioning NET that started in the pancreas
doctors don’t know where your cancer started (unknown primary)
you have had another cancer in the past 5 years apart from basal cell skin cancer
you have had cancer treatments in the past month
you are going to have other cancer treatments such as chemotherapy, radiotherapy, chemoembolisation or immunotherapy
doctors think you can have surgery to try to cure the NET
you still have moderate or serious side effects from previous cancer treatment
you have had treatment with everolimus or any other similar drug
you have had PRRT

Medical conditions
You:

have had an investigational treatment in the past month
have any other serious medical condition or mental health problem that the trial team think could affect you taking part
have had a live vaccine in the last month
are sensitive to any of the treatments used in this trial or anything they contain

Trial design

This is an international phase 3 trial. Researchers need around 300 people to take part.

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

peptide receptor radionuclide therapy (PRRT) with 177 Lu-edotreotide
standard treatment with everolimus

Neither you nor your doctor will be able to decide which group you are in. And you are 2 times more likely to have PRRT than everolimus.

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PRRT with 177 Lu-edotreotide
You have PRRT as a drip into your bloodstream. It takes up to 20 minutes to have it. You also have a drip with proteins called amino acids to protect the kidneys. It takes 4 to 6 hours to have the amino acids drip.

You have PRRT and the amino acids once every 3 months. This continues for 9 months (up to 4 doses of treatment).

Your doctor and nurse explain how long you need to stay in hospital and the precautions you need to take.

Everolimus
You have everolimus as a tablet that you swallow whole every day. This continues for as long as it is helping you and the side effects aren’t too bad. It can be for up to 2 and a half years.

Doctors will ask you to keep a diary to record each time you take everolimus. This helps your doctor know how many doses of treatment you have had.

Tissue sample
The trial team will ask to use a sample of your cancer taken at the time of your diagnosis. You need to have a biopsy if there isn’t a suitable sample available.

Doctors want to look at the cancer and the proteins (receptors) on the outside of cancer cells.

Quality of life
You complete a quality of life questionnaire before the start of treatment and at set times during the trial.

The questionnaires ask about how you have been feeling and what side effects you have had.

Hospital visits

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

a physical examination
blood tests and urine test
heart trace (ECG)
CT scan or MRI scan

During treatment, you see the trial team for blood tests and physical examinations. You also have CT scans or MRI scans.

When you finish treatment, you see the trial team every 6 months, for 5 years.

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 the possible side effects before you start the trial.

The most common side effects of PRRT with 177 Lu-edotreotide are:

a drop in the number of blood cells increasing your risk of infection, tiredness and breathlessness
feeling or being sick
tummy (abdominal) pain
tiredness (fatigue) during and after treatment
loss of appetite
changes in your bowel habit
dizziness

PRRT has a small amount of radiation. As a precaution, you should avoid close contact with young children and pregnant women for the first 2 weeks after treatment. Close contact means being within arm’s length.

Your doctor or nurse tells you about all the precautions you need to take before you go home.

The most common side effects of everolimus are: