A study comparing capecitabine and Teysuno (TOFFEE)

Cancer type:

Bile duct cancer
Biliary tree cancers
Bowel (colorectal) cancer
Cancer of unknown primary (CUP)
Colon cancer
Gallbladder cancer
Liver cancer
Oesophageal cancer
Pancreatic cancer
Rectal cancer
Small bowel cancer
Stomach cancer

Status:

Open

Phase:

Phase 2

This study is comparing the 2 chemotherapy drugs capecitabine (Xeloda) and Teysuno.

Chemotherapy is one of the main treatments for cancer. As with all treatments there are possible side effects.

Capecitabine is a chemotherapy drug that is widely used. Although a rare side effect, capecitabine can affect how your heart works. Doctors aren’t sure why this happens. But when it does you may need to stop treatment.

Teysuno is a chemotherapy drug that is similar to capecitabine. It has been widely used for a number of cancers in the world. And there have been no reports of heart problems as a side effect.

In this study the researchers want to compare capecitabine with Teysuno. They want to try and find out why capecitabine may cause heart problems and also if Teysuno may be safer than capecitabine.

The aims of this study are to find out

  • If Teysuno causes fewer heart problems then capecitabine
  • If people who already have damage to their heart are more likely to get heart problems if they take capecitabine or Teysuno
  • How capecitabine or Teysuno causes heart problems

Who can enter

You can join this study if you are going to the Edinburgh Cancer Centre, have one of the following cancers and it has spread to another part of your body

You must also

  • Be able to have the chemotherapy drug capecitabine either by itself or alongside the chemotherapy drug oxaliplatin
  • Have satisfactory blood test results
  • Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Be willing to use reliable contraception during treatment if there is any chance you or your partner could become pregnant
  • Be at least 18 years old

You cannot join this study if any of these apply. You

  • Have had serious heart problems in the past 6 months
  • Are taking blood thinning medication, such as warfarin
  • Aren’t able  to take capecitabine or similar drugs
  • Aren’t able to lie flat
  • Have any other medical or mental condition that could affect you taking part in this trial

Trial design

This is a phase 2 study. The study team need 60 people who are going to the Edinburgh Cancer Centre to join.

It is a randomised study. 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. You have treatment in periods of 3 weeks. Each 3 week period is called a cycle of treatment.

  • People in group 1 have capecitabine for one cycle of treatment
  • People in group 2 have Teysuno for one cycle of treatment

TOFFEE study diagram

Capecitabine and Teysuno are tablets. Your doctor will tell how many to take and when. This depends on the type of cancer you have.

After your 1st cycle of treatment, your doctor will decide if you are to have Teysuno or capecitabine.

As part of the study you wear a portable heart monitor. You wear it for a day (24 hours) before starting your treatment. You also wear it continuously for 3 days during the 1st week of treatment.

TOFFEE study portable heart monitor

The researchers will take extra blood samples before you start treatment and weekly for the 1st treatment cycle. They will use these to try and understand how your treatment is affecting your blood and blood vessels.

The researchers will also ask 24 people to have some tests on the blood vessels of their forearm. These tests will look at how well your blood vessels are working before treatment and afterwards. For this you will need to lie flat and still for at least 4 hours while you have measurements and blood samples taken. If you agree to this, you have the forearm tests before starting treatment and again about a week later. Enough people have agreed to have these tests done so the researchers are no longer asking people.

Hospital visits

You see a member of the research team to talk about the study and make sure it is the right thing for you before agreeing to take part.

You see the research team again before starting treatment to have some tests. These tests include

  • CT scan of your heart
  • Blood tests
  • Heart trace (ECG Open a glossary item)

You wear the portable heart monitor for 24 hours.

During your first cycle of treatment you see the researchers once a week for blood tests and a heart trace. You wear the portable heart monitor for 3 days.

If you agree to have the forearm tests, you have these done during the visit before starting treatment and again about a week later.

Side effects

You may have some bruising and bleeding from where you have the blood samples taken.

We have more information about the side effects of capecitabine.

Location

Edinburgh

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Sally Clive

Supported by

Cancer Research UK
Edinburgh Cancer Research Centre
Experimental Cancer Medicine Centre (ECMC)
KIS fund for colorectal cancer research
NHS Lothian
NIHR Clinical Research Network: Cancer
Nordic Pharma group
Scottish Cancer Research Network
University of Edinburgh

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11419

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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