
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using either everolimus (Afinitor) or pasireotide alone, or both together, for people with neuroendocrine tumour (NET) of the lung or thymus.
Neuroendocrine tumours (NETs) are a rare group of cancers that make and release hormones. This trial is for people who have NET that started in the lung or the .
Doctors often use drugs called somatostatin analogues to help control the symptoms of NETs. Research suggests that these drugs may also help stop NETs growing. Pasireotide is a new type of somatostatin analogue.
Everolimus is a biological therapy. It stops signals that cancer cells use to divide and grow. We know from research that everolimus may be useful to treat NETs.
This trial is comparing everolimus and pasireotide together with either everolimus or pasireotide alone. The aim of the trial is to find out which is best at shrinking or slowing down the growth of neuroendocrine tumours of the lung or thymus.
You may be able to enter this trial if all of the following apply
You cannot enter this trial if any of these apply. You
This is a phase 2 trial. This international trial will recruit 120 people across Europe.
It is a randomised trial. The people taking part will be put into 1 of 3 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.
Everolimus is a tablet. You take 2 tablets once a day, with or without food. You need to avoid eating grapefruit, Seville oranges and marmalade and drinking grapefruit juice while taking part in the trial as these can all stop everolimus from working properly.
You have pasireotide as an injection into the muscle once every 4 weeks.
You have treatment for 12 months. But if your tumour is not getting worse and you don’t have bad side effects, you may be able to carry on having treatment for longer.
You see the doctor and have some tests before you start treatment. These tests may include
You go to hospital 3 times during the 1st month of treatment then every 4 weeks after that. If you have pasireotide, you have an extra visit about 3 weeks after your 2nd injection.
You cannot eat or drink anything apart from water for 8 hours before each hospital appointment.
During treatment you have a heart trace every 2 to 4 weeks to begin with and then every 3 months. You will have a CT, MRI or octreoscan every 3 months. At most visits you have a blood test and give a urine sample.
If you have pasireotide the trial team will ask you to check your blood sugar throughout your treatment. They will give you a blood sugar monitor and instructions on how to use it. They will also give you a diary to record the results. Approximately 10 days after your 1st and 5th treatments, the trial team will call you to ask for your blood sugar results.
If your blood sugar level is high on any 2 separate occasions or is very high on any occasion, you will need to contact the trial team immediately as you may need to go to hospital.
If you stop treatment because of side effects you will have a CT or MRI scan every 3 months until you either start a new treatment or you cancer begins to grow again.
The trial team will contact you around 2 months after you finish treatment to see how you are.
The possible side effects of pasireotide include
As with any new treatment, it is possible that there could be some side effects the doctors don’t know about yet.
The most common side effects of everolimus include
We have more information about the side effects of everolimus.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Tim Meyer
NIHR Clinical Research Network: Cancer
Novartis
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.