"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of buparlisib with paclitaxel for head and neck cancer that has come back or spread to another part of the body
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called buparlisib (also known as BKM120) for squamous cell cancer of the head and neck. This includes cancer that that started in the mouth, the nose or sinuses, the back of the throat or the voice box (larynx).
Doctors often use chemotherapy drugs called
In this trial, researchers want to see if having a drug called buparlisib alongside paclitaxel helps people in this situation. Buparlisib (pronounced boo-parl-is-ib) is a type of biological therapy. It is a cancer growth blocker. It works by blocking the action of proteins called PI3K (it is a PI3K inhibitor).
The aim of the trial is to see if paclitaxel and buparlisib works better than paclitaxel and a dummy drug (
Who can enter
You may be able to enter this trial if
- You have
squamous cell cancerof the head and neck such as cancer that started in the mouth, the nose or sinuses, the back of the throat or the voice box (larynx)
- Your cancer has come back or spread to another part of your body despite having chemotherapy that included a
- You have cancer that can be seen and measured on a scan
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are able to swallow tablets
- You are at least 18 years old
- You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain and is causing symptoms. You may be able to take part if you have cancer spread to your brain that isn’t causing symptoms as long as you finished any treatment for this at least 4 weeks ago, and if you need to take steroids, it is a low dose
- Are currently having any other anti cancer drugs
- Have already had a drug that targets the PI3K protein or other proteins called AKT or mTOR
- Have already had more than 1 type of chemotherapy for cancer that has come back or spread
- Have already had chemotherapy that included a
taxane drugfor cancer that has spread
- Have had radiotherapy in the last 4 weeks, or in the last 2 weeks if it was radiotherapy to treat symptoms (palliative radiotherapy)
- Still have side effects from other treatment (apart from hair loss) unless they are very mild
- Have had major surgery in the last 2 weeks, or haven’t recovered from earlier surgery
- Have been taking
steroidsfor more than 5 days (steroid creams, inhalers and eye drops are allowed)
- Take other medication that affects body substances called CYP enzymes or that can affect your heart rhythm (your doctor can advise you about this)
- Take drugs to thin your blood (anticoagulants) such as warfarin
- Have had a heart attack in the last 6 months or have certain other heart problems (the trial tram can advise you about this)
- Have problems with your
digestive systemthat could affect how you absorb the trial drug
- Have had mental health problems in the past, or have moderate to severe depression, suicidal thoughts or severe anxiety (doctors use questionnaires to assess these)
- Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
- Have any other serious medical condition that the trial team think could affect you taking part
- Are known to be very sensitive to paclitaxel or a drug made in a similar way
- Are known to have HIV
- Are pregnant or breastfeeding
This phase 2 trial will recruit about 150 people in a number of different countries. It is a randomised trial. 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. And neither of you will know which group you are in. This is called a double blind trial.
Everybody taking part will have paclitaxel through a drip into a vein once a week.
Half the people taking part will also take buparlisib capsules every day. The other half will take dummy capsules (
As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you.
The trial team will ask you to fill out questionnaires before you start treatment, every 2 weeks for the first 3 months and then every month after that. The questionnaires will ask about how you’re feeling (your mood) including whether you are anxious or depressed.
Every 6 weeks, they will also ask you to fill out a questionnaire asking about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Heart trace (
- Heart scan (
echocardiogram) or MUGA scan
- CT scan or MRI scan
- Blood tests
- Urine test
To be able to take part in this trial, the researchers need a sample of your cancer that was taken when you had surgery or a
You go to hospital once a week to have paclitaxel. You have a blood test at each visit. Every 4 weeks you have a physical examination and a heart trace. You have a heart scan every 4 months. You have more urine tests if and when needed.
You have a CT or MRI scan after the first 4 weeks of treatment, then every 6 weeks after that.
When you finish treatment, you will see the trial team again about a month later. After that, they will phone you every 3 months to see how you are.
If you stop the trial treatment for a reason other than your cancer getting worse, or starting a different treatment, the trial team may ask you to carry on having CT or MRI scans every 6 weeks until you do start another type of treatment, or your cancer starts to grow.
As buparlisib is a new drug, there may be side effects we don’t know about yet. In other trials, the most common side effects of buparlisib have been
- Loss of appetite
- Feeling or being sick
- Tummy (abdominal) pain
- Feeling weak or tired (fatigue)
- Sore mouth
- Shortness of breath
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Changes to how your liver works
- Diarrhoea or constipation
- Skin rash which may be itchy
- Mood changes
- Change to your blood sugar levels
The most common side effects of paclitaxel include
How to join a clinical trial
Dr Martin Forster
NIHR Clinical Research Network: Cancer