A trial of ganetespib with pemetrexed and cisplatin or carboplatin for pleural mesothelioma (MESO 2)
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 a drug called ganetespib alongside standard chemotherapy for mesothelioma in the covering of the lungs (the pleura). The trial is supported by Cancer Research UK.
Mesothelioma is a type of cancer that can develop in the tissues covering the lungs or lining the 
. Mesothelioma affecting the lungs is called pleural mesothelioma.
Doctors can treat mesothelioma with chemotherapy. The chemotherapy drugs they normally use are pemetrexed and cisplatin or carboplatin.
In this trial, researchers want to see if they can improve the treatment of pleural mesothelioma by adding a drug called ganetespib.
Ganetespib is a type of biological therapy called a heat shock protein 90 inhibitor. It stops signals that cancer cells use to divide and grow.
The aims of this trial are to
- Find the best dose of ganetespib to give alongside pemetrexed and cisplatin or carboplatin
- See how well this combination of drugs works as treatment for pleural mesothelioma
Who can enter
You may be able to enter this trial if you
- Have pleural mesothelioma that can be measured on a CT scan
- Have had a small piece of tissue (
biopsy ) taken from your cancer that confirms you have pleural mesothelioma - Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood tests results
- 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 already had treatment for pleural mesothelioma – if you had valproic acid and your last dose was a month ago you may be able to take part
- Your mesothelioma has spread to your brain or spine and your doctor thinks you should have chemotherapy to treat it
- You have a serious heart problem
- You are HIV, hepatitis B or hepatitis C positive
- You have had another cancer in the last 3 years apart from non melanoma skin cancer or carcinoma in situ of the cervix
- You have had surgery in the last 4 weeks apart from removal of the sheets of tissue covering the lungs (pleurectomy) or sealing the space between the sheets of tissue covering the lungs (
pleurodesis ) - You have had significant weight loss (10% or more of your body weight) in the last month
- You have had a vaccination for yellow fever in the last month
- You have any other condition that may affect you taking part in this trial
- You are planned to have surgery or any other treatment that could affect you taking part in this trial
- You are pregnant or breastfeeding
Trial design
This trial is in 2 stages. The first stage is a phase 1 trial. The researchers want find the best dose of ganetespib to give with pemetrexed and cisplatin or caboplatin. To do this they will give the first 3 people a low dose of ganetespib with the usual doses of pemetrexed and cisplatin or carboplatin. If they don’t have any problems, the next 3 people have a higher dose of ganetespib. And so on, until they find the best dose to give. This is called a dose escalation study.
The second stage is a phase 2 trial. It is randomised. 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.
- Group A have ganetespib, pemetrexed and cisplatin or carboplatin
- Group B have pemetrexed and cisplatin or carboplatin
You have ganetespib, pemetrexed, cisplatin and carboplatin as a drip into a vein. You have pemetrexed and cisplatin or carboplatin once every 3 weeks and ganetespib twice every 3 weeks. Each 3 week period is called a cycle of treatment. You can have up to 6 cycles.
If you are in the group having ganetespib, after 4 cycles of treatment your doctor may talk to you about continuing with ganetespib only, if they feel you are benefitting from it.
The researchers will ask for blood samples and a sample of tissue from the you had to diagnose your mesothelioma. They will use these samples to find out more about mesothelioma and how to treat it. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.
Hospital visits
You see the doctor and have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Urine test
- Heart trace (
ECG ) - CT scan
During treatment you see the doctor every 3 weeks for a physical examination, blood tests and a heart trace.
When you finish treatment, you see the doctor every 6 weeks for a year and then every 3 months.
Side effects
The most common side effects of the drugs used in this trial include
- Feeling or being sick
- Diarrhoea or constipation
- A drop in blood cells causing an increased risk of infection, bruising or bleeding, tiredness and breathlessness
- Sore mouth
- Numbness or tingling in your hands or feet
- Tiredness
- Eye problems
- Skin changes
- Hair loss
- Changes to your hearing
- Changes to the way your kidneys work
- Loss of appetite and taste changes
- An allergic reaction causing hot flushes, backache, headaches or swelling of the face and feelings of tightness in the chest - if this happens the nurse can stop the drip and restart it when the symptoms have gone
Ganetespib may cause the heart to beat in a slightly unusual way. Your heart will be monitored regularly during the study to see how well it is working.
Pemetrexed may cause your body to hold more fluid. Let your doctor know if you notice any swelling or puffiness in different parts of the body (particularly your ankles and feet).
Many of these side effects are due to standard treatment (carboplatin or cisplatin and pemetrexed), which you would be given if you didn’t take part in the trial.
Your doctor will talk to you about the 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
Professor Dean Fennell
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Synta Pharmaceuticals
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUKE/09/025.
We have more information about the work of Prof Dean Fennell.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
