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:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Status:

Closed

Phase:

Phase 2

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.