A trial looking at curcumin and FOLFOX for advanced bowel cancer (CUFOX)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer

Cancer spread to the liver

Secondary cancers

Status:

Closed

Phase:

Phase 1/2

This trial is looking at curcumin with FOLFOX chemotherapy for bowel cancer (colorectal cancer) that has spread to the liver.

More about this trial

Doctors often treat bowel cancer that has spread with chemotherapy. The combination of chemotherapy they usually use is called FOLFOX. It is made up of the drugs folinic acid (leucovorin), fluorouracil (5FU) and oxaliplatin. But this doesn’t always work very well. And it often causes side-effects such as numbness and tingling in hands and feet (peripheral neuropathy). This means the doctors sometimes need to lower the dose or even stop chemotherapy, so they are keen to improve treatment.

Curcumin is a plant extract found in the spice turmeric and is found in many everyday foods. We know from research that curcumin can help shrink tumours in the laboratory. It has also been used in several studies involving patients with a range of conditions, including cancer.

Researchers hope that curcumin might help FOLFOX work better as a treatment for advanced bowel cancer, and that it might also reduce peripheral neuropathy. If it does, it may mean that patients can have treatment for longer.

The aims of this early phase trial are to find out

The best dose of curcumin to give with FOLFOX chemotherapy
About the side effects of having curcumin and FOLFOX together
If curcumin can reduce chemotherapy side effects
More about what happens to curcumin in the body
How well curcumin and FOLFOX work as a treatment for advanced bowel cancer

Who can enter

You may be able to enter this trial if you

Have bowel cancer (colorectal cancer) that has spread to the liver
Have an area of cancer that can be measured on a scan
Are not able to have surgery to treat your cancer
Are due to have FOLFOX chemotherapy
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Are prepared to use reliable contraception while you are taking part in the trial
Have satisfactory blood test results
Are at least 18 years old

You cannot enter this trial if you

Have bowel cancer that has spread to your bones
Have bowel cancer that has spread to your brain, unless you have had radiotherapy or surgery and it has now stopped growing
Are not able to have FOLFOX chemotherapy
Are due to have cetuximab for bowel cancer that has spread to the liver
Have had a major operation, chemotherapy, hormone therapy or biological therapy in the last 4 weeks
Have had radiotherapy in the last 4 weeks, unless it was for symptom control only
Have had a lot of radiotherapy which has affected your bone marrow (your doctor can tell you about this)
Are taking part in any other clinical trial
Have had any other cancer in the last 5 years (apart from basal cell skin cancer or carcinoma in situ of the cervix)
Have heart problems such as congestive heart failure or angina, or you have had a heart attack in the last 6 months
Have a condition, such as a bowel obstruction, which means you can’t absorb medication from your stomach
Have Hepatitis B, Hepatitis C or HIV
Have any other serious medical condition
Are pregnant or breast feeding

Trial design

This is an early phase trial and will be run in 2 parts – phase 1 and phase 2. It will recruit about 42 people altogether. Everyone taking part will have bowel cancer that has spread to the liver.

The people who took part in phase 1 started taking curcumin capsules 7 days before they started FOLFOX chemotherapy. They took the curcumin capsules every day while they were having chemotherapy.

The first few people taking part had the lowest dose of curcumin. Then the next few people started at a slightly higher dose. Then a third group of people took the highest dose. The research team were able to decide the best dose to give in phase 2. This is called a dose escalation trial.

The trial is now in phase 2, which will recruit 33 people. This part is randomised and will recruit people into one of two groups – group A and group B. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group A will recruit 22 people to have FOLFOX and curcumin
Group B will recruit 11 people to have FOLFOX alone

If you are in group A you start taking curcumin capsules 7 days before starting FOLFOX chemotherapy. The dose of curcumin you have will be the best dose found in phase 1 of the trial. You take curcumin capsules every day for as long as you have chemotherapy.

Everyone in group A and group B will have FOLFOX chemotherapy through a drip into a vein once every 2 weeks. Each 2 weeks is one cycle of treatment. You will have up to 12 cycles over 6 months.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. These include the standard tests you have before starting chemotherapy, such as

Physical examination
CT scan
Heart trace (ECG)
Blood tests

You have more blood tests before each cycle of chemotherapy. You have a CT scan every 3 months for 2 years, and then every 6 months for another 2 years.

You fill out a diary every day for the first 4 weeks of treatment. It will ask you about any side effects you are having.

At various stages of the trial you complete 3 short questionnaires.

The first asks you if you are having any changes in feeling in your hands or feet such as numbness or tingling. You do this one every second cycle of chemotherapy.
The second asks you how you are feeling, about your quality of life and what, if any, symptoms you are having. You fill this one in before you start treatment and again when you finish treatment.
The third asks you about curcumin and how you feel about taking it in this trial, and with chemotherapy. You fill this one in before you start treatment and again when you finish treatment.

Side effects

Curcumin is a new potential treatment for cancer, so there may be side effects we don’t know about yet. It has been used in about 40 or so small clinical trials so far - some used doses similar to those in this trial, some used higher doses.

From this research we know that the possible side effects include

Mild bowel disturbance, such as looser stools or diarrhoea
Bloating and increased wind

Some people who had a higher dose of curcumin had no severe side effects, but some had diarrhoea and abdominal pain.

We have more information about the side effects of FOLFOX.

Recruitment start:

02/02/2012

Recruitment end:

11/02/2016

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.

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Chief Investigator

Prof Anne Thomas

Supported by

Bowel Disease Research Foundation (BDRF)
Experimental Cancer Medicine Centre (ECMC)
Hope against cancer
NIHR Clinical Research Network: Cancer
Royal College of Surgeons of England
University Hospitals of Leicester NHS Trust
University of Leicester

Freephone 0808 800 4040

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