Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of a chemotherapy drug called nab-paclitaxel with gemcitabine for cancer of the pancreas that has spread (SIEGE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
Doctors usually treat pancreatic cancer that has spread with chemotherapy. Gemcitabine is a chemotherapy drug they often use. But a large international trial has shown that combining gemcitabine with a drug called nab-paclitaxel worked better than gemcitabine alone.
Nab-paclitaxel is the chemotherapy drug paclitaxel (also known as Taxol) combined with a protein called albumin.
In this trial, researchers are looking at 2 different ways you can have nab-paclitaxel and gemcitabine. You either have both drugs on the same day, or you have nab-paclitaxel 24 hours before you have gemcitabine.
The people taking part have not had any other treatment for pancreatic cancer that has spread so doctors call this
The aims of the trial are to
- See which way of having nab-paclitaxel and gemcitabine works best as first line treatment for pancreatic cancer that has spread
- Learn more about how nab-paclitaxel works against pancreatic cancer
Who can enter
You may be able to enter this trial if you
- Have the most common type of pancreatic cancer called ductal adenocarcinoma
- Have cancer that has spread from your pancreas to another part of your body (stage 4 or metastatic cancer)
- Haven’t had any other treatment that reaches your whole body (
systemic treatment) for pancreatic cancer that has spread (you can take part if you had chemotherapy after surgery to try to stop your cancer coming back, as long as this finished at least 6 months ago)
- Have at least one area of cancer that can be measured on a scan and has not been treated with radiotherapy
- Are able to care for yourself, even if you aren’t able to carry on with all your normal activities or do active work (you score 70 or more on the Karnofsky performance scale)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have pancreatic cancer that can be removed with surgery, or has spread only into tissues surrounding the pancreas
- Have had any other cancer in the last 5 years apart from non melanoma skin cancer or prostate cancer that hadn’t spread outside the prostate gland and was successfully treated
- Have had a heart attack in the last 6 months or have certain other heart or lung problems (the trial team can advise you about this)
- Have an active infection
- Have hepatitis B, hepatitis C, or certain other types of liver disease (the trial team can advise you about this)
- Have any other medical condition or mental health problem that the trial team think could affect your taking part
- Are known to be allergic (or very sensitive) to gemcitabine or nab-paclitaxel
- Take certain supplements or vitamins (the trial team can advise you about this)
- Are pregnant or breastfeeding
This phase 2 trial aims to recruit 120 people at a number of hospitals in the UK. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody has 4 week cycles of treatment. You have gemcitabine and nab-paclitaxel through a drip into a vein once a week for 3 weeks, followed by a week without treatment. It takes half an hour to have each drug. People in one group have gemcitabine straight after each dose of nab-paclitaxel. People in the other group have gemcitabine 24 hours after each dose of nab-paclitaxel.
As long as you don’t have bad side effects and your cancer doesn’t get worse, you have 6 cycles of treatment. But if the treatment is helping, your doctor may talk to you about continuing to have it for longer.
The trial team will ask you to fill out a questionnaire before you start treatment, every 4 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- CT scan or MRI scan (unless you’ve had one of these in the last 4 weeks)
- Heart trace (
The trial team need a sample of your cancer before you start treatment. If you’ve had a
If you are in the group having gemcitabine straight after nab-paclitaxel, you go to hospital 3 times every 4 weeks. If you are in the group having gemcitabine 24 hours after nab-paclitaxel, you go to hospital 6 times every 4 weeks. Travel expenses for the extra 3 visits are available because these would not normally be part of standard chemotherapy.
You have regular blood tests. You have a CT or MRI scan every 8 weeks to see whether the chemotherapy is working.
The trial team may ask you to have another biopsy during the 3rd cycle of treatment. And they will also ask you to have a biopsy if your cancer gets worse. But you don’t have to agree to have them if you don’t want to. You can still take part in the trial.
When you finish treatment, you see the trial team again about a month later. You then see them every 3 months, but if you stopped the trial treatment for any reason other than your cancer growing, you will see them every 4 weeks until your cancer does start to get worse.
The most common side effects of both nab-paclitaxel and gemcitabine include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Sore mouth
- Skin rash
- Flu like symptoms
Other common side effects of nab-paclitaxel include
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Diarrhoea or constipation
- Loss of appetite and weight loss
- Hair loss
Other common side effects of gemcitabine include
- High temperature after you have the drug
- Temporary swelling in your face, hands and feet
- Changes to the way your liver works
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 Pippa Corrie
Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer