A trial looking at selumetinib and paclitaxel for a type of eye cancer called uveal melanoma (SelPac)
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 selumetinib and paclitaxel for a type of eye cancer called uveal melanoma. It is for people whose uveal melanoma has spread elsewhere in the body. This trial is supported by Cancer Research UK.
More about this trial
Most melanomas start in the skin, but they can develop in other parts of the body, including the eye. Melanoma that starts in the uvea (the middle tissue layer of the eyeball or choroid) is called uveal melanoma.
Doctors usually treat uveal melanoma that has spread with chemotherapy or biological therapy or a combination of the two. Researchers are continually trying to find the best drugs to use.
Selumetinib is a type of biological therapy. It works by targeting a protein called MEK (so it is called a 
. MEK is a protein that sends signals to cells telling them to divide and grow.
Previous trials have shown that selumetinib may help to treat uveal melanoma that has spread. Very early research in the laboratory suggests that using selumetinib alongside a chemotherapy drug called paclitaxel may improve treatment.
The aim of the trial is to see if selumetinib and paclitaxel works better than selumetinib alone for uveal melanoma. The researchers will also try to find the best way to give these 2 drugs together.
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have a type of cancer called uveal melanoma that has spread to another part of the body
- Have cancer that can be measured using scans, or by the doctor examining you
- Have satisfactory blood test results
- Are able to swallow tablets
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during treatment if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression) and this hasn’t been treated or is causing symptoms. You can take part if cancer spread to your brain has been treated with surgery or radiotherapy, has not got worse in the last 4 weeks and if you have not needed to take steroids or anti epileptic drugs in the last 4 weeks
- Had any kind of cancer treatment in the last 3 weeks
- Have already had chemotherapy for your uveal melanoma (including chemotherapy into the liver’s blood supply or
chemoembolisation) . You may be able to take part if you have any other local treatments to the liver (that have not included chemotherapy) and your cancer has continued to grow despite this treatment - Are still having side effects from any anti cancer treatment, apart from hair loss
- Have already had treatment with drugs that block the action of certain proteins called MEK, Ras or Raf
- Are allergic to the drugs used in this trial
- Have had any other cancer in the last 3 years apart from non melanoma skin cancer that was successfully treated
- Have certain heart problems
- Are HIV positive
- Have hepatitis B or hepatitis C
- Have a medical condition or have had treatment that means your body cannot absorb tablets so well. For example, conditions such as coeliac disease or past surgery to remove part of your bowel of stomach
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The researchers need 123 people to join.
It is a randomised trial. The people taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everyone has selumetinib. People in the other 2 groups also have paclitaxel.
- One group has selumetinib on its own
- Another group has selumetinib and paclitaxel
- The other group has selumetinib and paclitaxel except for 2 days before each treatment with paclitaxel
If you are in the 1st group, you have 3 selumetinib capsules twice a day, every day, at least 12 hours apart. You take the capsules with 240 mls of water. You need to have these on an empty stomach, no food and drink (other than water) for 2 hours before and 2 hours after.
If you are in 2nd group, you have selumetinib capsules in the same way as the 1st group. You go to hospital to have paclitaxel through a drip into a vein (an infusion), this takes about 1 hour. You have this once every week for 3 weeks, then no paclitaxel in the 4th week. Each 4 week period is called a cycle of treatment.
If you are in the 3rd group, you have selumetinib and paclitaxel in the same way as the 2nd group. Except that you do not take any selumetinib for 2 days before each paclitaxel treatment. You then start taking your capsules again on the day of your chemotherapy treatment.
If you are having paclitaxel, you have up to 6 cycles. Then you continue taking selumetinib twice a day, every day.
You continue selumetinib treatment for as long as it is helping you and you don’t have any serious side effects.
The researchers will ask for your permission to look at a sample of your cancer removed when you had surgery or a . They may also ask if they can carry out a biopsy of your cancer at the end of your treatment. They want to look for to find out why treatment might work for some people and not for others.
You are asked to provide extra blood samples as part of this trial at various points throughout the trial. Where possible you have these at the same time as your routine blood tests. These samples will be used to help the researchers learn more about uveal melanoma.
You don’t have to agree to these extra blood and cancer samples if you don’t want to. You can still take part in the trial.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Heart trace (
ECG ) - Heart scan (
echocardiogram ) or MUGA scan - Eye examination
- CT scan of your chest and
abdomen
You may also have an MRI scan. Everyone has further have blood tests before each cycle of treatment (every 4 weeks). If you are having paclitaxel, you also have blood tests in the 2nd and 3rd week of each cycle (before each paclitaxel infusion).
During treatment you have
• CT scans (and possibly an MRI scan) about every 2 months
• An echocardiogram or MUGA scan every 3 months
If you develop any problems with your vision, you have regular eye examinations during and after treatment if necessary.
If you stop treatment in this trial, you have a final appointment with a doctor in the trial team. They will examine you and ask about any side effects. Your care will then continue with your own doctor who can discuss other treatment options and support with you.
If you stop treatment in this trial and your cancer has stayed the same and not started to grow (stable disease), you may have a CT scan every 2 months.
Side effects
As selumetinib is a new drug, there may be side effects we don’t know about yet. If you have any of the following you should contact your medical team or study doctor immediately as you may need treatment
- Diarrhoea
- Fever
- Breathing difficulties and coughing
- Chest pain or
palpitations - Blurred vision
- Swelling of face, arms and legs due to a build up of fluid (oedema)
Side effects also include
- Tiredness (fatigue)
- Skin changes such as rash, peeling, dryness and being more sensitive to the sun
- Sore mouth
- An increase in blood pressure, your nurse will check your blood pressure regularly
- Feeling or being sick
The most common side effects of paclitaxel are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Low blood pressure, your nurse will check your blood pressure regularly
- Sore mouth
- Diarrhoea
- Hair loss
- Aching joints and muscles
- Numbness and tingling in your hands and feet (peripheral neuropathy)
We have more information about paclitaxel.
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
Dr Paul Nathan
Supported by
AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Liverpool
Other information
This is Cancer Research UK trial number CRUK/13/033.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
