A trial of pazopanib for merkel cell skin cancer (UKMCC-01)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Neuroendocrine tumour (NET)

Non melanoma skin cancer

Skin cancer

Status:

Closed

Phase:

Phase 2

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.

In this trial they are looking at a drug called pazopanib. Pazopanib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

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 system in 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

Trial design

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 biopsy Open a glossary item . If there is no sample available, they will ask you to have a new biopsy when you join the trial.

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.

Hospital visits

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 (ECG )

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.