A trial looking at zoledronic acid and chemotherapy for people with mesothelioma (Zol-A)
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 for people with cancer that started in the lining of the lungs (pleural mesothelioma). It is for people who:
- are going to have chemotherapy for the first time
- have decided not to have chemotherapy
More about this trial
Mesothelioma can start in the lining of the lungs or the tummy (
). When it starts in the lining of the lungs it is called pleural mesothelioma.
Pleural mesothelioma is often treated with chemotherapy. You usually have either:
Zoledronic acid (Zometa) is a bisphosphonate. It can be used to reduce the risk of fractures in cancer that has spread to the bones. But doctors think it might also improve the way certain chemotherapy drugs work and could even have an anti cancer effect.
They want to find out if it can help people with pleural mesothelioma.
In this trial you have 1 of the following:
- chemotherapy and zoledronic acid
- chemotherapy and a dummy drug (placebo)
If you have decided not to have chemotherapy you can have just zoledronic acid.
The main aim of this trial is to find out if it is possible to do a larger study looking at how good zoledronic acid is at helping people with pleural mesothelioma.
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.
You may be able to join this trial if all of the following apply:
- You have pleural mesothelioma
- Your doctor thinks you are well enough to have chemotherapy
- You have at least 1 area of cancer that can be seen and measured on a CT scan
- Your kidneys are working well
- You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are at least 18 years old
You cannot join this trial if any of these apply:
- You have had chemotherapy for your pleural mesothelioma
- You have had a bisphosphonate (such as zoledronic acid or disodium pamidronate) as a drip into your vein (intravenously) in the past 3 months
- You have or have had a low level of
calcium (hypocalcaemia) in the last 6 weeks - You are sensitive to bisphosphonates or the
contrast used during a PET scan - You have serious problems with your teeth such as tooth decay that hasn’t been treated
- You are taking part in another mesothelioma trial
- You are a woman and able to become pregnant
Trial design
This is a feasibility study. The researchers need about 50 people who are going to have chemotherapy and about 20 people who have decided not to have chemotherapy to take part.
For the people who are going to have chemotherapy this trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:
- chemotherapy and zoledronic acid
- chemotherapy and a dummy drug (
placebo )
Neither you nor your doctor are able to decide which group you are in. Also, neither you nor your doctor will know which group you are in. This is called a double blind trial.
If you have decided not to have chemotherapy, then you can have zoledronic acid on its own.
Chemotherapy
The chemotherapy you have is the same as the . You have the drug pemetrexed (Alimta) with either:
You usually have chemotherapy once every 3 weeks. This is a cycle of treatment. You can have up to 6 treatment cycles.
Zoledronic acid or dummy drug
You have zoledronic acid or a dummy drug as a drip into a vein (intravenously). This is followed by chemotherapy, if you are in the group having this treatment.
You have treatment once every 3 weeks. It takes about 15 minutes each time. You have up to 6 treatments (this takes around 6 months in total).
You also take supplements of and phosphate. This is because zoledronic acid can lower the amount of these salts in your blood. You doctor can tell you for how long and how often you should take the supplements for.
Blood tests
You have some extra blood tests as part of this trial. Researchers want to look for a protein called mesothelin.
You have the extra blood tests before the start of treatment and before each cycle of treatment. These samples will be taken at the same time as your routine blood tests.
PET CT scan
You have 2 PET CT scans as part of this trial. You have the scan:
- before the start of treatment
- after the 3rd treatment of zoledronic acid or dummy drug
Researchers want to find out if PET CT scans can help tell how well treatment is working.
Interview
The study team may ask you to have an interview at the end of your treatment. They want to find out what you think about this trial.
Researchers hope that about 10 people will agree to take part in this interview.
Hospital visits
You see a doctor and have some tests before taking part. These tests include:
- a physical examination
- blood tests
- a CT scan
During treatment you see the trial doctor for blood tests and a physical examination every 3 weeks. Then you see the doctor:
- at the end of treatment
- 6 months after the end of treatment
You have a CT scan after 3 cycles of chemotherapy or zoledronic acid and at the end of treatment.
Side effects
The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
The most common side effects of zoledronic acid are:
- flu like symptoms (such as fever, headache, chills, aching muscles)
- feeling sick
- low levels of calcium and phosphate in your blood
- loss of appetite
- kidney problems
- a drop in red blood cells (anaemia) causing tiredness and breathlessness
- sore eyes (conjunctivitis)
- inflammation around the drip site causing soreness and redness
We have more information about zoledronic acid.
And information about:
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
Professor Nick Maskell
Supported by
NIHR Research for Patient Benefit (RfPB) Programme
North Bristol NHS Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
