A study of lanreotide for neuroendocrine tumours of the pancreas or small bowel that have spread (PRODIGE 31, REMINET)

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

Cancer type:

Neuroendocrine tumour (NET)

Status:

Closed

Phase:

Phase 2/3

This study is for people with a neuroendocrine tumour that started in the pancreas or small bowel (duodenum) and cannot be removed with surgery.

More about this trial

Neuroendocrine tumours (NET’s) are rare tumours that develop in the nerve or gland cells that make up the neuroendocrine system. They are normally found in all the body but are most common in the digestive system Open a glossary item .

If the first treatment you have for your NET helps control the growth of the tumour, you don’t usually have more treatment straight away.

You are followed up at regular hospital appointments and only have further treatment if the tumour starts to grow again.

In this study, doctors want to see if a drug called lanreotide can help:

keep the tumour under control
increase the time before you need to start other treatment that could be more demanding

This is called maintenance treatment.

Lanreotide is a man made form of a drug called somatostatin Open a glossary item . It is already used to treat NET’s of the bowel and pancreas. It reduces the secretions of hormones in the cells and also slows the tumour growth.

The aims of the study are to:

find out if lanreotide is a useful maintenance treatment
learn more about the side effects

Who can enter

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

You may be able to join this study if all of the following apply.

You have a single or several neuroendocrine tumours (NET) that started in the pancreas or small bowel (duodenum ) and have grown into surrounding tissues (locally advanced) or spread elsewhere in the body
You have a NET that doesn’t produce extra hormones or a type of tumour called a gastrinoma
A specialist doctor called a pathologist has looked at a sample of your tumour that was removed when you had a biopsy
You have a slow growing tumour (the tumour is low to medium grade)
You have had treatment because:
- the tumour started causing symptoms, grew into more than half of the liver or spread to the bone and this is your first treatment
- the tumour has grown before this treatment or after a previous treatment with somatostatin analogues such as lanreotide

The first treatment you had included chemotherapy for 3 to 6 months or a biological therapy such as everolimus or sunitinib for 6 months
Your tumour stayed the same size or shrunk after the first treatment and this was within 4 weeks of joining the study
You have satisfactory blood test results
You are well enough to be up and about for at least half the day (performance status 0,1 or 2)
You are willing to use reliable contraception during treatment and for up to 6 months afterwards if you are a women and for 3 months afterwards if you are a man - if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot join this study if any of these apply.

The neuroendocrine cells look very abnormal under the microscope (they are poorly differentiated cells) or you have a fast growing (high grade) tumour
The area where the tumour started (the primary tumour) has been completely removed and the tumour areas remaining are just in the bone
You have a family history of neuroendocrine tumours – for example you have a condition called MEN1
You have diabetes that is not well controlled with medication
You have had any other cancer in the last 5 years apart from non melanoma skin cancer or early stage cancer of the cervix (CIS) that was successfully treated
You are taking part in another trial of an experimental drug or have taken part in a trial within 30 days of starting study treatment
You can’t have treatment with the study drug or you are allergic to it or anything it contains
You are pregnant or breastfeeding

Trial design

This phase 2/3 study is being run in the UK and Europe. It is in 2 parts. The study team need 118 people to join part 1.

If results from part 1 suggest that lanreotide is a useful maintenance treatment, the study will continue in a part 2 to confirm these results. This is the phase 3 part of the study.

It is a randomised study. You are put into 1 of 2 treatment groups by a computer.

one group have lanreotide
the other group have a dummy drug (placebo )

study diagram
Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which treatment you are having. This is called a double blind study.

You have lanreotide or the dummy drug as an injection into your bottom cheek (buttock) once a month.

You have treatment for as long as it works and the side effects aren’t too bad.

Hospital visits

You see the study doctors and have some tests before you start treatment. These include:

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

You go to hospital to have the injections. You see the study doctors once a month for a check up. You have some blood tests and a CT or MRI scan every 3 months.

If the tumour gets worse you stop treatment. You then see the study team every 6 months for check up. Your doctor will talk to you about other treatment options.

If you stop treatment for any other reason, you see the study team every 3 months.

The study team will ask you to fill out some questionnaires before you start treatment and then every 3 months. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

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

They will also ask for 3 extra blood samples. Where possible, you have these at the same time as your routine blood tests.

All these samples are used to look for substances called biomarkers Open a glossary item . Biomarkers help to predict who is most likely to benefit from this treatment and also help us to better understand neuroendocrine tumours.

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