Cancer Research UK on Google+ Cancer Research UK on Facebook Cancer Research UK on Twitter
Skip navigation

A trial looking at standard treatment with or without celecoxib for transitional cell bladder cancer (BOXIT)

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

This trial is comparing standard treatment and celecoxib with standard treatment alone for bladder cancer. It is recruiting people with a very early type of bladder cancer that doctors call superficial transitional cell bladder cancer. This trial is supported by Cancer Research UK.

Doctors usually treat superficial transitional cell bladder cancer by removing the cancer (tumours) from the bladder. Doctors call this procedure a trans urethral resection of bladder tumours, or TURBT. Some people will also have treatment into the bladder (intravesical). For example, intravesical chemotherapy or intravesical BCG. Despite this treatment, some people have an increased risk of their bladder cancer coming back (recurring).

Doctors think that adding celecoxib to standard treatment may reduce the risk of recurrence and so improve treatment. Celecoxib is a type of drug called a COX-2 inhibitor. It is a type of anti inflammatory drug. COX-2 inhibitors block the action of a protein that may help cancer cells to grow.

In this trial people will have standard treatment and either

The trial aims to find out if adding celecoxib to standard treatment will be even better at stopping the cancer from growing back.

Doctors also want to learn more about the side effects of celecoxib.

Recruitment

Start 01/11/2007
End 31/08/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

You cannot enter this trial if

Trial design

This national trial will recruit 475 people with superficial transitional cell bladder cancer. It is a randomised trial. The people taking part are put into 2 different treatment groups by computer. Half the people in the trial will have treatment with celecoxib and the other half will have treatment with a placebo (dummy drug). Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial.

First of all you will have your cancer removed with surgery (TURBT) and one treatment of mitomycin C chemotherapy into your bladder (intravesical treatment). You will then continue to have treatment with intravesical mitomycin C chemotherapy or you will have intravesical BCG.

These are standard treatments used for bladder cancer. Which treatment you have depends on your individual case. Your doctor will explain how often you have this treatment and for how long.

You will also have celecoxib or a placebo (dummy drug). You have 2 capsules once a day for up to 2 years.

You will be asked to fill out a questionnaire before you start treatment and 1, 2 and 3 years after starting treatment. If you have BCG as part of your treatment, you will fill in the questionnaire more frequently. The questionnaire will ask you about any side effects you have and about how you have been feeling. This is called a quality of life study.

The researchers will ask for a sample of your cancer (tissue sample) that was removed during your TURBT. They will also ask for extra blood and urine samples. These will be used for future research to help doctors understand which treatments are best for which patients. This is called a ‘Sample Collection Sub Study’. If you don’t want to give extra samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

Before you can take part in this trial a doctor will examine you and you will have various tests. The tests include

If you have BCG as part of your treatment, you will go to the hospital to see the doctor and have blood tests

  • Every 3 months in the first and second year
  • Every 6 months after that

If you do not have BCG as part of your treatment, you will go to the hospital to see your doctor and have blood tests

  • Every 3 months in the first year
  • Every 6 months in the second and third year
  • Yearly after that

You will have several examinations of the inside of your bladder (cystoscopies) during the trial. The cystoscopy test will be done on the same day as your appointments to see your doctor.

You will also have a heart trace (ECG) once a year while you are taking celecoxib or placebo (dummy drug). And one year after you stop taking it.

Side effects

All treatments have side effects. The most common side effects of celecoxib are

  • Indigestion
  • Diarrhoea
  • Stomach pain

Very rarely, some people may develop a stomach ulcer, or have a stroke or heart attack while taking celecoxib. But the risk of this happening is very small. Your doctor will explain this risk to you in more detail.

The side effects of intravesical chemotherapy and BCG are usually mild. This is because the drugs tend to stay in your bladder. Very little of it gets into the bloodstream.

Some side effects of mitomycin C into the bladder may include

  • Passing urine more often than usual
  • Rash on your hands and feet

Some of the side effects of BCG into the bladder are

  • A feeling that you need to pass urine very often
  • Blood in your urine

There is more about treatment into the bladder in the main bladder cancer section of CancerHelp UK.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Prof. J Kelly

This is Cancer Research UK trial number CRUK/07/004.

Supported by

Cambridge Laboratories
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Kyowa Hakko UK Limited
National Institute for Health Research Cancer Research Network (NCRN)
Rate this page:
Submit rating
Rate this page
Rate this page for no comments box
Please enter feedback to continue submitting
Send feedback
Question about cancer? Contact our information nurse team

No Error

Updated: 2 November 2012