
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 drugs called capecitabine and aflibercept for people who have bowel cancer that has spread elsewhere in the body.
Doctors often use chemotherapy to treat bowel cancer when it has spread from where it started to another part of the body (advanced or metastatic bowel cancer). They can use fluorouracil or capecitabine with either irinotecan or oxaliplatin. But irinotecan and oxaliplatin can cause serious side effects so many people just have fluorouracil or capecitabine.
In this trial, researchers want to see whether adding a drug called aflibercept to capecitabine will be a better treatment than capecitabine alone.
Aflibercept stops cancers forming blood vessels. Reducing the blood supply may help to stop the cancer from growing.
The aims of this trial are to
You may be able to join this trial if all of the following apply.
You must be willing to use contraception during the trial if there is any chance you or your partner could become pregnant. Women taking part in the trial must continue to use contraception for up to 3 months afterwards. If you are a man taking part in the trial and your partner could become pregnant you must each agree to use different types of contraception during the trial.
The trial is in 2 parts. Part 1 has now closed.
To be able to join the second part of the trial, the following must apply
You cannot enter either part of this trial if you
This is a phase 2 trial. It is in 2 parts. Part 1 has now closed. For part 2 the doctors need about 32 people to join. Everyone will have capecitabine and aflibercept.
In the first part of the trial, the researchers were trying to find the best dose of capecitabine you can have with aflibercept.
In part 2 the researchers want to see what the side effects will be for people who are less fit.
You have aflibercept through a drip into a vein every 3 weeks. You have it over 1 to 2 hours.
After you have the aflibercept, the trial team will give you your capecitabine tablets, which you take twice a day for 14 days. You then have a week without treatment.
Each 3 week period is called a cycle of treatment .
After 12 weeks the doctors will check whether the treatment is working. If it is you can have up to 8 cycles, lasting about 6 months in total.
If the drugs are continuing to help you, it may be possible for you to have more aflibercept. Your doctor will discuss this with you.
In part 2 of the trial, the researchers ask you to complete a questionnaire before you start treatment and then after 3 months and 6 months.
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. A research nurse will also go through a couple of questionnaires with you at the same time covering a range of areas including how you manage everyday activities. You may hear the questionnaires called a comprehensive health assessment.
You see the trial team and have some tests before you start treatment. The tests include
Before every treatment you will have a physical examination and blood tests. At 3 and 6 months, you will have a heart scan (echocardiogram) and a CT scan.
After you have your last treatment the researchers will follow up with you for a month. If you have serious side effects from the treatment the doctors will continue to see you every month until the side effects get better or until you start another cancer treatment.
The most common side effects of capecitabine are
The most common side effects of aflibercept are
We have more information about capecitabine and aflibercept.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Paul Ross
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
Sanofi Aventis
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.