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.
A trial looking at everolimus and pasireotide for neuroendocrine tumours of the pancreas (COOPERATE 2)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using everolimus (Afinitor, RAD001) in combination with a new drug called pasireotide for people with neuroendocrine tumours of the pancreas.
Neuroendocrine tumours (NETs) are a rare group of cancers that make and release hormones. They are normally found in the
Doctors often use drugs called somatostatin analogues to help control the symptoms of NETs. These work by binding to receptors on the tumour cells. 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 works by stopping a protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. By blocking mTOR, everolimus helps to stop the cancer growing. We know from research that everolimus may be useful to treat NETs.
The aim of this trial is to compare everolimus and pasireotide with everolimus alone to find out which is the best treatment for neuroendocrine tumours of the pancreas.
Who can enter
You may be able to enter this trial if
- You have a neuroendocrine tumour (NET) of the pancreas that cannot be removed with surgery or has spread to another part of your body
- You have had a scan that shows your tumour has grown in the last year
- Your tumour can be measured on a scan
- You have satisfactory blood test results
- You are well enough to up for at least half the day (performance status 0, 1 or 2)
- You are willing to use reliable contraception during treatment and for 8 weeks after if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have already had pasireotide
- Have already had everolimus or a similar drug
- Have had chemotherapy, biological therapy or a somatostatin analogue in the last 4 weeks
- Have had more than 2 treatments that affect the whole body (
- Have had a radio labelled somatostatin analogue in the last year
- Have had hepatic artery embolisation, cryoablation (cryotherapy) or radiofrequency ablation in the last 3 months
- Have had radiotherapy in the last 4 weeks – you may be able to join if your radiotherapy was to control symptoms and you have recovered from any side effects
- Have had any major surgery in the last month or surgery to remove an area of cancer spread (
metastases) in the last 3 months
- Are having ongoing treatment with
steroidsor any other medication that can suppress the immune system
gallstonesthat are causing symptoms
- Have problems with your
thyroid gland– you may join if you have an underactive thyroid gland that has been controlled with medication and has been stable for the last 3 months
- Have problems with blood clotting
- Have a serious heart problem
- Have had another cancer in the last 3 years apart from non melanoma skin cancer that has been removed with surgery or in situ carcinoma of the cervix
- Are HIV positive
- Have another medical condition that could affect you taking part in this trial
- Have had an experimental drug as part of another clinical trial in the last month
- Are known to be sensitive to everolimus, pasireotide or similar drugs and their ingredients
- Are pregnant or breastfeeding
This is a phase 2 trial. This international trial will recruit 150 people from around the world.
It is a randomised trial. The people taking part will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.
People in group 1 will have everolimus only. People in group 2 will have everolimus and pasireotide.
Everolimus is a tablet. You take 2 tablets once a day. You can have them with food or without food. If you start taking them with food you must continue to do so. If you start taking them without food you must continue to do so.
You continue having treatment along as the side effects aren’t bad and it is still helping you.
You will see the doctor and have some tests before you start treatment. These tests may include
During treatment for the first 3 cycles you see the doctor at the start of each cycle and at week 3 for a physical examination and blood tests. You then see the doctor at the beginning of each cycle of treatment. You cannot eat for 8 hours before each doctor’s appointment.
You have a CT scan or MRI scan every 3 months. If you are in the group having everolimus and pasireotide you will also have a heart trace (ECG) every 3 months.
At the end of treatment you see the doctor for a physical examination and blood tests. If you were having everolimus and pasireotide you will have a heart trace. You see the doctor again about 2 months later for the same tests.
The most common side effects of pasireotide include
- Tummy (abdominal) pain
- Feeling or being sick
- Weight loss
- Pain, swelling or redness at the injection site
The injections can affect levels of hormones in your body such as insulin, which regulates your blood sugar levels. The trial team will measure your blood sugar levels during the trial.
Pasireotide may also affect your heart rhythm. You have regular heart traces (ECGs) during the trial to check this.
The most common side effects of everolimus include
- Sore mouth or throat
- Feeling or being sick
- Dry mouth
- Dry itchy skin or rash
- Loss of appetite or changes in taste
- Tummy (abdominal) pain
- Swelling of the arms and legs
- Nose bleeds
- Change in sleeping patterns
- A drop in the blood cells causing an increased risk of infection, bruising and bleeding
- Shortness of breath
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Juan Valle
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)