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

Cancer type:

Bladder cancer

Transitional cell cancer

Status:

Results

Phase:

Phase 3

This trial looked at celecoxib for a very early type of bladder cancer called superficial transitional cell bladder cancer. It was supported by Cancer Research UK.

More about this trial

When this trial was done, doctors usually treated superficial transitional cell bladder cancer with an operation called a trans urethral resection of bladder tumour, or TURBT. Some people also had treatment such as mitomycin C or BCG directly into the bladder to help stop it coming back.

Doctors hoped that having celecoxib as well as standard treatment might reduce the risk of the cancer coming back even more.

Celecoxib is a type of anti inflammatory drug called a COX-2 inhibitor. It helps block the action of a protein that may help cancer cells to grow.

In this trial people had standard treatment and either celecoxib or a dummy drug (placebo).

The main aims of this trial were to find out:

whether adding celecoxib to standard treatment helps stop bladder cancer coming back
more about the side effects of celecoxib

Summary of results

The research team found that celecoxib did not help stop transitional cell bladder cancer coming back.

This trial was open for people to join between 2007 and 2012, and the research team published the results in 2019.

About this trial

A total of 472 people joined this trial. They were all due to have treatment for early stage transitional cell bladder cancer.

The people taking part were put into 1 of 2 treatment groups at random:

236 people had celecoxib tablets twice a day for 2 years
236 people had dummy (placebo) tablets twice a day for 2 years

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Results
The research team looked at how many people’s cancer had started to grow again 3 years after joining the trial. They found it was similar in the two groups:

76 people (32%) who’d had celecoxib
86 people (36%) who’d had the placebo

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When they looked at how many people had died, it was also similar in the two groups:

26 people (11%) who’d had celecoxib
21 people (9%) who’d had the placebo

Side effects
About 8 out of 10 people had at least one side effect, but many were mild or didn’t last long. About 3 out of 10 people in each group had a more severe side effect including tummy (abdominal) pain, difficulty sleeping and needing to pass urine more often than usual.

Some of the people taking part had heart (cardiac) related side effects such as a heart attack. These were a bit more common in the celecoxib group, affecting:

12 people (5%) who had celecoxib
4 people (2%) who had the placebo

Quality of life

The people taking part filled out questionnaires when they joined the trial, and again 6 months and 2 years later. The research team compared the results to see how their quality of life had changed.

They found that people’s quality of life had gone down a bit in both groups, 6 months and 2 years after joining the trial. The score had gone down a little bit more for those in the celecoxib group. But this could have been chance rather than because of the different treatments.

Stopping the trial

Research teams running clinical trials regularly look at all the information gathered so far. This is to make sure the trial is running smoothly and the treatment being tested is not causing any harm to the people taking part.

In 2013, the research team running BOXIT decided to stop the trial earlier than planned because:

the results so far showed that it was unlikely people would have any benefit from taking celecoxib
there was a small increased risk of heart related side effects

Conclusion

The research team concluded that celecoxib did not help stop transitional bladder cancer coming back after treatment. It also caused some extra heart related side effects.

They do not recommend that celecoxib is used as a treatment for bladder cancer. But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.

Where this information comes from

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item

) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.