"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 EZN-2208 for bowel cancer that has spread
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 EZN-2208, with or without cetuximab for bowel cancer that has spread to another part of the body.
In this trial, researchers are looking at a new drug called EZN-2208. It is made by joining SN38 to a substance called a glycol. This process is called
We know from research that cetuximab does not help people whose cancer cells have a change (a
The aim of the trial is to see if EZN-2208 helps people with advanced bowel cancer
- In combination with cetuximab for cancer that has a normal K-RAS gene
- On its own for cancer with an abnormal K-RAS gene
Who can enter
You can enter this trial if you
- Have bowel cancer that has spread into surrounding tissue or to another part of your body and cannot be removed with surgery
- Have already had the chemotherapy drugs irinotecan, oxaliplatin and 5FU (or a similar drug), and your cancer has got worse during this treatment or within the next 3 months
- Have at least one area of cancer that can be seen and measured on a scan
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have had more than 2 other types of treatment for advanced bowel cancer after which your cancer has got worse
- Have cancer that has spread to your brain and you need to have
steroidsor radiotherapy to control symptoms (you can take part if you have cancer that has spread to your brain but has been successfully treated, no longer causes symptoms and you don’t need steroids)
- Have already had cetuximab, panitumumab or similar drugs, unless you were then found to have an abnormal K-ras gene, or you had cetuximab after surgery to try to stop your cancer coming back and it was more than a year before your cancer started growing again
- Have had chemotherapy,
immunotherapyor any other cancer treatment in the last 3 weeks (6 weeks if you had a drug called mitomycin C)
- Have not recovered from the side effects of other cancer treatment (apart from hair loss) unless they are very mild
- Have had major surgery in the last 3 weeks
- Have had an experimental drug as part of another clinical trial in the last month
- Have had another cancer in the last 5 years apart from non melanoma skin cancer or cervical cancer that has been cured with surgery
- Have AIDS or a long term infectious disease
- Have any other medical condition that the trial doctors think could affect you taking part
- Are pregnant or breastfeeding
This is a phase 2 trial. It will recruit about 220 people. The treatment you have will depend on K-RAS testing of your cancer. If you have a mutated K-RAS gene, you will be in group A. If you have a normal K-RAS gene you will be put into either group B or group C. Neither you nor your doctor will be able to decide which of these 2 groups you are in. This is called randomisation.
- People in group A have EZN-2208 alone
- People in group B have EZN-2208 and cetuximab
- People in group C have irinotecan and cetuximab
People in group A have treatment in 4 week periods called treatment cycles. In each cycle they have EZN-2208 once a week for 3 weeks, followed by a week without any treatment.
People in group B also have 4 week cycles of treatment. They have cetuximab once a week for 4 weeks and EZN-2208 once a week for the first 3 weeks of each treatment cycle.
People in group C have 3 week cycles of treatment. They have cetuximab and irinotecan once a week for the first 2 weeks of each cycle, then cetuximab alone in the 3rd week.
You have all 3 drugs through a drip into a vein
- EZN-2208 takes about an hour each time
- Cetuximab takes about 2 hours the first time you have it and about an hour each time after that
- Irinotecan takes about an hour and a half each time
Treatment is expected to last 4 months, but this may be shorter or longer, depending on your response to treatment.
The trial team will ask your permission to take some extra blood samples during the trial. And they may ask to get an extra sample of tissue that was removed when you had surgery or a
You will see the doctors and have some tests before you start treatment. The tests include
Depending on which group you are in, you go to hospital 3 or 4 times in each treatment cycle.
During treatment and at certain times after you finish treatment, you will have blood tests and a scan or X-ray. The trial team will follow your progress every 3 months for at least 6 months. This may be at hospital appointments, or they may contact you by phone to see how you are.
As EZN-2208 is a new drug, there may be side effects we don’t know about yet. From earlier trials, the researchers know the most common side effects include
- A drop in the number of red and white blood cells causing an increased risk of infection, tiredness and breathlessness
- Feeling or being sick
- Diarrhoea or constipation
- Tiredness (fatigue)
- Loss of appetite
- Hair loss
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 David Cunningham
Enzon Pharmaceuticals Inc
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)