“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of pazopanib for merkel cell skin cancer (UKMCC-01)
This trial is looking at a drug called pazopanib for merkel cell skin cancer that has spread. The trial is supported by Cancer Research UK.
Merkel cell carcinoma (also known as MCC) is a rare type of skin cancer. Doctors sometimes use chemotherapy for MCC that has spread and can’t be removed with surgery or controlled with radiotherapy. Chemotherapy often helps, but unfortunately MCC usually comes back. So researchers are looking for new treatments to help people with advanced MCC.
The aims of the trial are to
- See if pazopanib helps people with merkel cell carcinoma that has spread
- Learn more about MCC and the effect that pazopanib has
Who can enter
You may be able to enter this trial if you
- Have merkel cell skin cancer (MCC) that has spread and can’t be removed with surgery or controlled with radiotherapy
- Have MCC that can be measured and has got worse despite having chemotherapy, or chemotherapy is not a suitable treatment for you
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Have recovered from the side effects of earlier chemotherapy unless they are very mild
- Are at least 18 years old
- Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have merkel cell cancer that has spread to your brain, unless this was treated with surgery or radiotherapy at least 6 months ago and there have been no signs of it getting worse since then
- Have merkel cell cancer that has spread to your airways or into blood vessels in your lungs
- Have had radiotherapy in the last 2 weeks
- Have had chemotherapy, biological therapy, hormone therapy or an experimental drug in the last 2 weeks
- Have had major surgery in the last 4 weeks or have a wound, ulcer or broken bone that won’t heal
- Have had any other type of cancer (there may be some exceptions to this which the trial doctor will be able to check)
- Have had bleeding in your brain or in your
digestive systemin the last 6 months
- Have coughed up blood in the last 6 weeks or have any other bleeding problems
- Have an infection that cannot be controlled with medication
- Have any problem with your digestive system that could affect how you absorb the trial drug
- Have high blood pressure that cannot be controlled with medication
- Have had a stroke or mini stroke in the last year
- Have had a blood clot in your lungs (pulmonary embolism) or in a large vein (deep vein thrombosis) in the last 6 months
- Have had a heart attack in the last 6 months or have certain other heart problems – the trial doctor can advise you about this
- Are known to be very sensitive to any drug that is similar to pazopanib
- Have had other drugs that target growth factors called VEGF or PDGF or have taken other medication that can affect body substances called CYP enzymes in the last 2 weeks (your doctor can confirm both these things)
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have any other medical condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This phase 2 trial will recruit 25 people. Everybody taking part has pazopanib.
You take pazopanib tablets once a day. The trial team will ask you to take them at the same time each day, 1 hour before eating, or 2 hours afterwards.
As long as you don’t have bad side effects, you can carry on taking pazopanib for as long as it helps you.
The researchers will get a sample of your cancer that was removed when you had surgery or a
If you have any more surgery or biopsies while you are taking pazopanib, they will also ask your permission to get tissue samples.
The trial team will ask permission to take photographs of your cancer during the trial. It will not be possible to see your face or identify you from the photos. If you don’t want to have photographs taken, you don’t have to. You can still take part in the trial.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests and urine tests
- CT scan
- Heart trace (
You may also have a bone scan.
You then see the trial team
- The day you start taking pazopanib
- 2 weeks later and 4 weeks later
- Every 4 weeks after that
During treatment you have
- An ECG after 8 weeks and then every 8 weeks after that
- A CT scan after 6 weeks and then every 8 weeks after that
You may have another bone scan after 4 weeks of treatment.
When you finish treatment, you see the trial team 4 weeks later and have a physical examination. They will ask you about any symptoms you have and any side effects from the treatment. You have a CT scan if you haven’t had one in the last 4 weeks.
After that, the trial team will want to check how you are every 2 months. You may see them at hospital, or they may contact you by phone.
If you stop pazopanib for a reason other than your cancer getting worse, you carry on having CT scans every 8 weeks. And the trial team may ask you to have other tests.
The researchers will ask your doctor to let them know how you are getting on for up to 5 years.
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.
Dr Paul Nathan
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
This is Cancer Research UK trial number CRUK/11/015.