A trial of 2 treatments for advanced neuroendrocrine tumours of the pancreas (SEQTOR)

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

Cancer type:

Neuroendocrine tumour (NET)

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is looking at the order of treatment for people with neuroendocrine tumours of the pancreas (pNETs).

It is for people who have a NET that has spread elsewhere in the body and that cannot be removed with surgery. This is advanced or metastatic cancer.

More about this trial

There are 2 usual treatments for neuroendocrine tumours (NET) of the pancreas that can’t be removed with surgery or have spread. These are:

streptozotocin (also called streptozocin) and fluorouracil (5FU)
everolimus

You have one treatment after the other. But doctors don’t know which order of treatment works best. So researchers are running this trial to find out more.

Streptozotocin and fluorouracil (5FU) are both chemotherapy drugs. Everolimus is a type of targeted drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In this trial you have 1 of these treatments to begin with. You have the second treatment only if your cancer gets worse. Or you might have the second treatment if you can’t tolerate the side effects of the first treatment.

The main aims of the trial are to:

find out which order of treatment works best
learn more about the side effects

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 neuroendocrine tumour of the pancreas that can’t be removed with an operation and has spread elsewhere in the body
have low grade NET of the pancreas (grade 1 or grade 2)
have a sample of tissue (biopsy ) available for the trial team to do some tests on
have cancer that the doctor can see and measure on a scan
have satisfactory blood test results
have cancer that got worse in the 12 months before joining the trial
are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
are willing to use reliable contraception for up to 30 days after treatment if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related
You:

have cancer cells that look very abnormal under a microscope and are growing quickly (grade 3 cancer)
have had chemotherapy and or certain targeted drugs such as sirolimus, everolimus, sunitinib, sorafenib or axitinib in the past
have had immunotherapy or radiotherapy in the 4 weeks before joining the trial
have had a substance such as a gel or tiny beads to block the blood supply to the NET spread to the liver (hepatic artery embolization) in the last 6 months or radiofrequency ablation in the last 2 months
have had a type of internal radiotherapy called peptide receptor radionuclide therapy (PPRT) in the last 6 months or you had this treatment and your NET hasn’t got worse
have another cancer apart from basal cell skin cancer , squamous cell skin cancer , a very early cancer (carcinoma insitu ) or any other cancer that has been successfully treated and there haven’t been any signs of it for 3 years
are taking part in another clinical trial using an experimental drug

Medical conditions
You:

have angina that isn’t well controlled with medication, congestive heart failure, a heart attack in the last 6 months or an abnormal heart rhythm that isn’t well controlled with medication
have an active infection or an infection that isn’t getting better with treatment
have severe liver damage
have a severe lung problem
have an increased risk of bleeding
have diabetes that isn’t well controlled with medication
are taking long term steroids or any other treatment that damps down the immune system
have HIV

Other
You:

are having treatment or herbal supplements that affect the CYP enzymes
are allergic to everolimus, 5FU or streptozotocin or anything they contain
have a low or no levels of an enzyme called DPD in your body (DPD deficiency)
are pregnant or breastfeeding

Trial design

This phase 3 trial is taking place in Europe and the UK. The trial team hope to find 140 people to take part including 4 from the UK.

The treatments in this trial aren’t new. You have them in the same way as if you weren’t in the trial. Neither you nor your doctor can decide which treatment you have first.

You are put into 1 of 2 treatment groups at random by a computer. You have 1 of the following:

streptozotocin and fluorouracil (STZ-5FU) followed by everolimus
everolimus followed by streptozotocin and fluorouracil (STZ-5FU)

SEQTOR trial diagram

Everolimus is a tablet. You take it once a day. You take them at the same time every day after a meal. The doctor tells you how long to take them for.

The trial team give you a diary to record when you take your tablets.

You have streptozotocin and 5 fluorouracil as a drip into a vein. You have treatment in cycles Open a glossary item . You have it as a:

6 weeks cycle or
3 week cycle

The trial team decide which is best for you. In the 6 week cycle you have treatment on the first 5 days of each cycle.

In the 3 week cycle you have treatment for the first 5 days in cycle 1. You then have treatment on the first day of each treatment cycle after that

Each treatment takes about an hour each time. The trial team tell you how long you have treatment for.

If the first treatment stops working or the side effects get too bad you stop treatment. You might then be able to start the second treatment. You have at least a 4 week break between finishing the first treatment and starting the second.

Quality of life
The trial team ask you to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire asks about any side effects you have had and about how you have been feeling. This is called a quality of life study Open a glossary item .

Blood and tissue samples for research
The trial team ask for a sample of cancer you gave when you were first diagnosed with a NET. They use this sample to look for genes that might be linked to NETs of the pancreas.

You give some blood samples to measure certain proteins. This might help doctors to work out how treatment is affecting your cancer.

The team also ask you to give 4 extra blood samples. This is to look for genes in your cancer. You don’t have to agree to this if you don’t want to. You can still take part in the trial.

Hospital visits

Before you join the trial, you see a doctor and have some tests. These include:

physical examination
blood tests
urine sample
heart trace (ECG )
a check of your lungs (lung function tests )
CT scan or MRI scan

You see the trial doctor once a month for a check up if you are having everolimus. In the chemotherapy group you have a regular check ups when you have your treatment at the hospital.

Everyone has a CT or MRI scan every 3 months.

When you stop treatment you see the team 1 month later for a check up. After that they phone you every 3 months to see how you are.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

The most common side effects of everolimus include: