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

Who can enter

You can enter this trial if you

• Have superficial transitional cell bladder cancer that has just been diagnosed or has come back after treatment
• Have a high or moderate risk of your bladder cancer coming back (the trial doctor will be able to explain whether this applies to you)
• Are over 18 years old
• Are well enough to take part in this trial (performance status 0, 1 or 2)
• Have satisfactory blood test results
• Have not taken celecoxib or non steroidal anti inflammatory drugs (NSAIDS) in the last 2 months
• Have a normal heart trace (ECG)
• Are willing to use reliable contraception (apart from the pill) when taking part in the trial if there is any chance that you or your partner may become pregnant

You cannot enter this trial if

• Your doctors think there is a low risk that your bladder cancer will come back after treatment (your doctor will tell you more about this)
• You have cancer of the prostate or cancer in your kidneys or the tubes leading to your kidneys
• You have invasive or advanced bladder cancer
• You have problems with bleeding
• You have heart failure or a history of heart disease
• You are allergic to celecoxib, other COX-2 inhibitors, sulphonamides (a type of antibiotic), salicylates (an ingredient of aspirin) or other non steroidal anti inflammatory drugs (NSAIDS)
• You have had another cancer in the last 2 years (apart from non melanoma skin cancer, carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast or lobular carcinoma in situ (LCIS) of the breast that was successfully treated, or prostate cancer that your doctors don't think will become life threatening in the next 5 years)
• You have any other serious medical conditions such as problems with your kidneys or pancreas, inflammatory bowel disease, insulin dependent diabetes, stomach ulcers or a stroke
• You are currently having chemotherapy unless it is treatment into your bladder (intravesical) with mitomycin C chemotherapy
• You are pregnant or breastfeeding
• You are taking or have taken steroid treatment for a long time (if you are taking low dose aspirin you may still be able to take part)

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

• Heart trace (ECG)
• Blood tests
• An ultrasound scan of your kidneys

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.