“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A study measuring doxorubicin blood levels in children and young people having treatment for solid tumours and leukaemia - The EPOC Study
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at the blood levels of the chemotherapy drug doxorubicin in children and young people who are having it as part of a
This study is for children and young people up to and including the age of 17. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
Doctors have used doxorubicin to treat cancer in children for many years. We know from research that people’s bodies vary in how they absorb and get rid of doxorubicin. The researchers want to find out more about why this is so.
They want to measure blood levels of doxorubicin in children and young people to find out if age makes a difference to how well the body absorbs and gets rid of doxorubicin.
You will not have any direct benefit from taking part in this trial. But the researchers hope that the information from this study will help improve the treatment of children and young people with cancer in the future.
Who can enter
You may be able to enter this trial if you
- Are between 0 and 2 and have any type of cancer
- Are between 3 and 17 and have Wilms’ tumour, neuroblastoma, soft tissue sarcoma, Ewing sarcoma or acute lymphoblastic leukaemia (ALL)
- Are between 0 and 2 years old and having doxorubicin according to a clinical trial protocol
- Are between 3 and 17 and having doxorubicin as part of specific clinical trials (you will need to check this with your doctor)
- Are to have at least 2 cycles of doxorubicin
- Are up and about and well enough to have treatment
- Are able to have additional blood samples taken – your doctor can advise about this
You cannot enter this trial if you have heart problems.
This is a phase 2 study. It will recruit 100 children and young people who are having doxorubicin as a part of their treatment.
Before treatment can begin, you will have a central line put in. This makes it easier to give chemotherapy and take blood samples.
You usually have chemotherapy as cycles of treatment. This means you have treatment for a number of days or weeks followed by a break for a number of weeks before the next cycle begins. The length of the cycles depends on which drugs you are having. In this trial, you will have blood samples taken from your central line at the start of your 1st and 2nd cycles of chemotherapy.
In the first cycle of treatment, you will have blood taken just before having doxorubicin and then have 5 more blood samples taken over the following 24 hours. In the second cycle of treatment, you will have a blood sample taken before having doxorubicin and then another 3 samples over the following 20 hours.
You give another sample 2 to 4 weeks after your second cycle of treatment. This will be done at the same time you give your routine blood samples.The researchers will measure the levels of doxorubicin in each blood sample. They will take one extra blood sample to see if there are any genetic factors affecting the level of doxorubicin in your blood.
On the days when you are giving blood samples during treatment, you will be at the hospital for most of the day. But you will be able to go out after your treatment and between the having blood samples taken.
When doctors and nurses use your central line, there is a risk of infection. The researchers will need to take extra blood samples from your central line in this study. But they will follow guidelines to make sure they take every precaution to lower infection risk when they use your central line.
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.
Professor Alan Boddy
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Newcastle upon Tyne Hospitals NHS Foundation Trust