A trial looking at Lutathera for carcinoid tumours of the small bowel (NETTER)

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 3

This trial is looking at Lutathera to treat carcinoid tumours of the small bowel.

Carcinoid tumours are rare and mostly slow growing tumours. They are a type of tumour of the neuroendocrine system. The neuroendocrine system is made up of nerve and gland cells that make hormones and release them into the bloodstream. There are neuroendocrine cells in the gut, lungs and pancreas. One of the most common places for carcinoid tumours to develop is the small bowel.

Doctors can treat carcinoid tumours of the small bowel with surgery. If you can’t have your tumour completely removed with surgery, doctors may use a drug called octreotide. Octreotide is type of drug called a somatostatin analogue. It works by stopping the cells in the gut producing too many hormones and changing the way the body reacts to hormones. It can control the growth of carcinoid tumours and their symptoms.

Lutathera is a targeted radiotherapy treatment. It is also called peptide receptor radionuclide therapy (PRRT). Lutathera is a somatostatin analogue with a radioactive part attached. It works by delivering the radioactive part directly to the carcinoid cells. The radioactive part then kills the cells.

We know from research that Lutathera may help people with carcinoid tumours of the gut and pancreas. The researchers think it may help people with carcinoid tumours of the small bowel.

The aim of this trial is to compare Lutathera with octreotide to find out which treatment is best for people with carcinoid tumours of the small bowel. They also want to find out more about the safety and side effects of Lutathera.

Who can enter

You may be able to enter this trial if

You have a carcinoid tumour of the small bowel that has spread to the surrounding tissue or to another part of your body and can’t be removed with surgery
Your tumour has a small amount of a protein called Ki67
All of your carcinoid tumours have somatostatin receptors
You are having 20 mg or 30 mg of octreotide every 3 or 4 weeks and have had it for at least 3 months
You have a CT scan or MRI scan that shows your tumour has grown in the past 3 years while having the same dose of octreotide
You have at least 1 tumour that can be measured on a scan
You have an octreoscan that shows equal to or greater than normal uptake of octreotide in your liver
You are well enough to carry out your normal activities but may need help from time to time (Karnofsky performance status 60 and above)
You have satisfactory blood test results
You are willing to use 2 reliable forms of contraception during treatment and for 6 months afterwards
You are at least 18 years old

You cannot enter this trial if

Your cancer has spread to your brain – if you’ve had treatment for this and haven’t had any symptoms in the past 6 months you may be able to take part
You are having more than 30mg of octreotide
You are having targeted radiotherapy treatment
You have had major surgery, radioembolisation or interferon in the past 6 weeks
You have had any other treatment, including an experimental drug as part of another clinical trial, in the past month
You are having short acting octreotide and cannot stop having it for short periods of time
You have had radiotherapy to more than a quarter of your bones that make blood cells
You have had another cancer apart from non melanoma skin cancer and carcinoma in situ of the cervix or any other cancer that has been successfully treated and there has been no sign of it in the past 5 years
You have certain heart problems
You have diabetes that isn’t controlled with medication
You are not able to control passing urine (urinary incontinence)
You have any condition that is not controlled by treatment and would affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. This international trial will recruit 230 people. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

The 2 groups are

Lutathera followed by octreotide
High dose octreotide

NETTER trial diagram

You have Lutathera as an injection into a vein. People having Lutathera will also have a protein solution as an injection into a vein. This is to protect your kidneys. It takes a total of 4 hours to have Lutathera and the protein solution. You have Lutathera and the protein solution every 2 months for 8 months. After this you have octreotide every month.

You have octreotide as an injection into a muscle. You have high dose octreotide every month.

You have treatment for about 1½ years.

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

To take part in this trial the trial team need a small piece of tissue (a biopsy) of your tumour. You must agree to this. If a tissue sample is not available from earlier surgery or biopsy, your doctor will talk to you about the possibility of taking a sample for this trial.

Hospital visits

You see the doctor and have some tests before taking part in this trial.

These tests include

A physical examination
Blood tests
Urine test
Heart trace (ECG )
CT scan
MRI scan
Octeroscan

During treatment you see the doctor regularly for the same tests. Your doctor will tell you how often this is depending on which group you are in.

After treatment you see the doctor every 6 months for 3 years to see how you are.

Side effects

The most common side effects of Lutathera include

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Feeling or being sick (nausea)
Tummy (abdominal) pain
Tiredness (fatigue)
Hair loss

The most common side effects of octreotide are