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A phase 2 trial which will add the drug paricalcitol to chemotherapy for advanced pancreatic cancer (PINBALL)
Research title: Paricalcitol Addition to Chemotherapy in Patients with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PINBALL)
Why is this trial being carried out?
Advanced pancreatic cancer is cancer that has spread away from the pancreas to other parts of the body. Surgery to remove the cancer won’t be possible, but some people may have chemotherapy to control the growth of the cancer and help with symptoms.
The PINBALL trial is looking at adding a drug called paricalcitol to chemotherapy for advanced pancreatic cancer. Paricalcitol can make cancer cells more sensitive to chemotherapy, so that the chemotherapy works better.
This trial will give paricalcitol together with a combination of chemotherapy drugs, which include:
The trial will see if adding paricalcitol will make the chemotherapy work better, and control the growth of the cancer for longer.
If you are already having the chemotherapy drugs nab-paclitaxel (Abraxane®) and gemcitabine, you may be able to join this trial to have paricalcitol added to your treatment. You can read more about this below.
Who is the trial suitable for?
The PINBALL trial may be suitable for you if you:
- have advanced pancreatic cancer
- are having nab-paclitaxel (Abraxane®) and gemcitabine chemotherapy in the same dose that this trial gives these drugs – your oncologist (cancer doctor) can tell you more about this
- are well enough to carry out day to day activities
- are able to have a biopsy at different time points during the trial
- are well enough to take part – your doctor or nurse can talk to you about this.
The PINBALL trial may not be suitable for you if you:
- have had radiotherapy or chemotherapy to treat advanced pancreatic cancer
- have had chemotherapy to treat advanced pancreatic cancer that isn’t nab-paclitaxel (Abraxane®) with gemcitabine – if you have had gemcitabine after surgery or alongside radiotherapy you may be able to take part in this trial
- are taking part in another clinical trial
- are taking herbal or dietary supplements, for example calcium supplements
- have cancer that has spread to your brain
- have had another type of cancer before, and haven’t been cancer free for more than two years
- have an infection that needs treating with antibiotics, anti-fungals or antiviral medicine
- have had kidney stones in the last year
- have peripheral neuropathy – which is tingling or numbness in your fingers or toes
- have a hearing impairment – this is because the chemotherapy drugs can affect your hearing
- have had pneumonitis, which is an inflammation of the lungs.
There may be other reasons for not being able to take part in this trial. It is important to speak to your oncologist (cancer doctor) about whether this trial is suitable for you.
What does the trial involve?
If you take part in this trial you will have a combination of the chemotherapy drugs nab-paclitaxel and gemcitabine. You may also have the drug cisplatin, but this is optional.
You will have chemotherapy until this treatment is no longer controlling the growth of the cancer, or the cancer becomes stable (it is not getting better or worse). If this happens, the drug paricalcitol will be given together with the chemotherapy.
You can have chemotherapy with paricalcitol for as long as this treatment is helping you and you don’t have any bad side effects.
It is also possible to join this trial if you are already having the chemotherapy drugs nab-paclitaxel (Abraxane®) and gemcitabine. If this is the case, you may be able to join the trial to have paricalcitol added to your treatment. To do this, you must be having the chemotherapy drugs in the same way and dose that this trial is giving them – your oncologist (cancer doctor) or the trial research team can tell you more about this.
How will the chemotherapy be given?
Nab-paclitaxel and gemcitabine are given by an infusion into a vein – you may hear an infusion called a ‘drip’. The infusion will take 30 minutes for each drug. These drugs will be given in a four-week cycle. This means that you will have treatment once a week for three weeks, and then have a break from treatment for a week.
Cisplatin is also given by an infusion into a vein – which will take 60 minutes. Cisplatin is given in a three week cycle. This means you will have treatment once a week for two weeks, and then have a break from treatment for a week.
Having cisplatin together with nab-paclitaxel and gemcitabine is optional. Your doctor can tell you more about cisplatin, and give you information on how the chemotherapy drugs will be given.
How is paricalcitol given?
Paricalcitol is given through a drip into a vein, which only takes a few minutes. It is given six times during each chemotherapy cycle, with a two or three day break between each paricalcitol treatment.
Your doctor or nurse can give you more information about your appointments, and how often you will need to visit the hospital for treatment during the PINBALL trial.
Recruitment start date: November 2018
Recruitment end date: June 2021
The PINBALL trial is being carried out in:
Barts Health NHS Trust, London, EC1M 6BQ
You can contact the trial centre: email@example.com
How to join a trial
Speak to your oncologist about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on freephone 0808 801 0707.
How to find out more
For further information about this trial go to the ClinicalTrials.gov website.
For references used to develop this information please email us.
Published: November 2019
Review date: November 2021