A trial looking at capecitabine and aflibercept for bowel cancer that has spread elsewhere in the body (CAPITAL)
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 2 drugs called capecitabine and aflibercept for people who have bowel cancer that has spread elsewhere in the body.
More about this trial
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
- Find the best dose of capecitabine you can have with aflibercept
- Learn more about the side effects of having both drugs together, particularly in people who are less fit
Who can enter
You may be able to join this trial if all of the following apply.
- You have bowel cancer that has spread to another part of your body (advanced or metastatic bowel cancer)
- You are not able to have surgery to treat your cancer
- You have satisfactory blood test results
- Your liver works normally
- You are at least 18 years old
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 are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are not able to have more than 1 chemotherapy drug (your doctor can advise you about this)
- You have not had any other treatment for advanced bowel cancer
You cannot enter either part of this trial if you
- Have cancer that has spread to your brain
- Are not able to have fluorouracil or capecitabine due to dihydropyrimidine dehydrogenase deficiency (DPD) (your doctors can advise you about this)
- Are not able to have a drug to stop diarrhoea, called loperamide
- Have not recovered from side effects of other treatment unless these are very mild (the trial doctors can advise you about this)
- Have had surgery in the last 4 weeks
- Have had a stomach ulcer or bleeding in your stomach or bowel in the last 3 months
- Have had inflammation of your food pipe (oesophagus), stomach lining, or bowel in the last 3 months
- Have had an abnormal opening between parts of the body (
fistula 
) or a split in the wall of your digestive system (perforation) - Have a blockage in your bowel (bowel obstruction)
- Have had a blood clot in your lung (a pulmonary embolism) in the last 3 months
- Have had a heart attack or stroke in the last 6 months or have certain other heart problems (the trial team can advise you about this)
- Have problems with bleeding or your blood not clotting
- Have high blood pressure that is not controlled with medication
- Have a high level of protein in your urine (your doctor can check for this)
- Have diabetes that is not well controlled with medication or diet
- Are known to be HIV, hepatitis B or hepatitis C positive
- Drink alcohol or take drugs and your doctor thinks this is a cause for concern
- Have any other serious medical condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
Trial design
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.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine tests
- CT scan
- Heart trace (
ECG ) - Heart scan (
echocardiogram )
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.
Side effects
The most common side effects of capecitabine are
- Changes to the way your kidneys work
- Diarrhoea
- Feeling or being sick
- Tiredness (fatigue)
- Redness and soreness of hands and feet (palmar-plantar syndrome)
- A sore mouth, sore nose or sore eyes
- A drop in white blood cells causing an increased risk of infection
- Bruising more easily from a drop in platelets
The most common side effects of aflibercept are
- Raised blood pressure
- Changes to the way your kidneys work
- A hoarse voice
- An increased risk of blood clots
- Feeling or being sick
- Diarrhoea
- Tiredness (fatigue)
- A sore mouth
We have more information about capecitabine and aflibercept.
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 Ross
Supported by
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
Sanofi Aventis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
