A trial looking at whether chemotherapy can shrink pancreatic cancer making surgery possible (PRICKLE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at using drugs called gemcitabine and nab-paclitaxel (Abraxane) for pancreatic cancer that has spread into the surrounding tissue. If pancreatic cancer has spread into surrounding tissue, it is called locally advanced cancer. It is not possible to remove locally advanced pancreatic cancer with surgery.
More about this trial
Doctors often treat locally advanced pancreatic cancer with the chemotherapy drug gemcitabine. Recent research has shown that combining gemcitabine with a drug called nab-paclitaxel worked better than gemcitabine alone. Nab-paclitaxel is another chemotherapy drug. It is also known as Abraxane.
In this trial, doctors want to see if giving gemcitabine and nab-paclitaxel will shrink locally advanced pancreatic cancer making it possible to remove it with surgery.
Who can enter
You may be able to enter this trial if you
- Have locally advanced adenocarcinoma of the pancreas that cannot be removed with surgery
- Have cancer that can be measured
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities apart from heavy physical work (performance status 0 or 1)
- Are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have pancreatic cancer that has spread to another part of your body
- Can have surgery to remove your cancer
- Have already had treatment for pancreatic cancer
- Have had a serious heart problem in the last 6 months, such as a heart attack or a problem with the rhythm of your heart
- Have had a stroke in the last 6 months
- Have had a blood clot in your lung (pulmonary embolism) or leg (deep vein thrombosis) and are still having problems with your blood clotting
- Have cirrhosis of the liver, hepatitis B or hepatitis C
- Have HIV
- Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or prostate cancer that hadn’t spread outside the prostate gland and was successfully treated
- Have any other medical condition that could affect you taking part in this trial
- Are known to be allergic or very sensitive to nab-paclitaxel or gemcitabine
- Take certain vitamin supplements that may interfere with gemcitabine (tell the trial team if you are taking any vitamins or use any other complementary therapies)
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The researchers need 17 people to take part.
Everybody has gemcitabine and nab-paclitaxel through a drip into a vein once a week for 3 weeks, followed by a week without treatment. This makes up a 4 week cycle of treatment. You have up to 6 cycles of treatment in total. Each time, it takes 30 minutes to have each drug. You have gemcitabine straight after each dose of nab-paclitaxel.
After 3 cycles of treatment you have a CT scan. If the scan shows that your cancer has shrunk, the trial team will see if it is possible to remove it with surgery. If you cannot have surgery, you go on to have another 3 cycles of chemotherapy. You then have another CT scan to see if you can have surgery.
You have either 3 or 6 cycles of chemotherapy in total but your treatment may stop sooner if
- The treatment isn’t working
- The side effects become too much
- You decide you wish to stop treatment
Hospital visits
You see the doctor and have some tests before taking part in this trial. These tests may include
- CT scan
- Blood tests
- Urine test
- Heart trace (
ECG 
) - Heart ultrasound (
echocardiogram ) - Endoscopic ultrasound scan and tumour
biopsy - Physical examination
An endoscopic ultrasound scan means that you have an ultrasound internally, via a tube put down your throat. The doctor will take a biopsy, guided by what they can see on the ultrasound. You will have a drug to make you drowsy (a ) before the scan to make you comfortable.
You have another CT scan, endoscopic ultrasound scan and biopsy 3 months after starting treatment. If you go on to have more chemotherapy, you have these tests again after 6 months.
The trial team may also ask you to have MRI scans. This is for research only. If you do agree to have these extra scans, you have one before treatment and another 3 months after starting treatment. You do not have to have the MRI scans if you would prefer not to, and can still take part in the trial.
You have your chemotherapy as an outpatient once a week for 3 weeks. You should not need to stay in hospital overnight. During these visits your doctors will ask how you are and you have a physical examination, blood and urine tests.
If you have surgery you will see the surgeon before the operation and have some blood tests, a urine test and an ECG. We have more information about having surgery for pancreatic cancer.
You see the trial team for a final visit 4 to 5 weeks after you have had surgery, or if you are not able to have surgery, after you finish your chemotherapy
Side effects
The most common side effects of both nab-paclitaxel and gemcitabine include
- A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and breathlessness
- Feeling or being sick
- Hair loss
- Diarrhoea
- Constipation
- Skin rash
- Flu like symptoms
- Loss of appetite and weight loss
- Taste changes
- Difficulty swallowing
- Headaches
- Tiredness (Fatigue)
- Trouble sleeping (insomnia)
- Sore throat or mouth
- Dry mouth
- Cough
- Tingling and numbness in your fingers and toes (peripheral neuropathy)
- Raised temperature
- Swelling of your hands, feet or face
- Drowsiness
- Sneezing, itchy, blocked or runny nose
- Dizziness or
vertigo Dehydration - Depression
- Nose bleeds
- Muscle weakness
- Pain in your muscles, joints, bones and chest
- Tummy (abdominal) pain or discomfort
This is not a complete list of side effects. You doctor or nurse will talk to you about other possible side effects before you agree to take part in the trial.
We have more information on
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Bristi Basu
Supported by
Cambridge Pancreatic Cancer Centre
Cambridge University Hospitals NHS Foundation Trust
Celgene
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
