A trial looking at zoledronic acid and chemotherapy for people with mesothelioma (Zol-A)

Cancer type:

Mesothelioma

Status:

Open

Phase:

Other

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 (abdomen Open a glossary item). 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 Open a glossary item (hypocalcaemia) in the last 6 weeks
  • You are sensitive to bisphosphonates or the contrast Open a glossary itemused 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 Open a glossary item

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.

study diagram

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 standard treatment Open a glossary item. 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 calcium Open a glossary item 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: 

Location

Bath
Bristol

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Nick Maskell

Supported by

NIHR Research for Patient Benefit (RfPB) Programme
North Bristol NHS Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14451

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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