A trial of cetuximab with chemotherapy and radiotherapy for muscle invasive bladder cancer (TUXEDO)

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

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Closed

Phase:

Phase 1/2

This trial is looking at a drug called cetuximab alongside radiotherapy and different types of chemotherapy for bladder cancer that has grown into the muscle layer (invasive bladder cancer). This trial is supported by Cancer Research UK.

More about this trial

If bladder cancer has grown into the muscle layer of the bladder wall, doctors can treat it with radiotherapy. We know from research that having chemotherapy at the same time as radiotherapy reduces the risk of the cancer coming back. Having chemotherapy before radiotherapy can also help.

Researchers now want to see if having a drug called cetuximab at the same time as radiotherapy and chemotherapy can further improve treatment. Cetuximab is a type of biological therapy called a monoclonal antibody.

The trial is in 2 parts. In part 1, the researchers look at different chemotherapy drugs alongside cetuximab and radiotherapy. In part 2, they look at just one of the drug combinations tested in part 1 to see if it reduces the risk of bladder cancer coming back.

The people taking part may have already had some chemotherapy to shrink their cancer before having radiotherapy. The aim of the study is to find out more about the best way to treat people with muscle invasive bladder cancer.

Who can enter

You may be able to enter this trial if you

  • Have bladder cancer that has grown into the muscle layer of the bladder wall, but has not spread to your lymph nodes Open a glossary item or to other parts of your body
  • Are able to have radiotherapy
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for up to a year afterwards if there is any chance you or your partner could become pregnant

If you had chemotherapy after your diagnosis (surgery) but before joining the TUXEDO trial, then your cancer must have responded well to this treatment.

You cannot enter this trial if you

  • Have carcinoma in situ of the bladder that is in more than 1 place in the bladder lining or is in a different part of the bladder from the invasive cancer
  • Have transitional cell cancer (TCC) in your kidney or the tube connecting the kidney to the bladder or TCC of your prostate
  • Have had any other type of cancer that the researchers think could affect the trial
  • Have taken part in another clinical trial in the last month
  • Have kidney damage from previous chemotherapy
  • Have had radiotherapy that included the area between your hip bones (your pelvis Open a glossary item)
  • Have a build up of urine in your kidney (hydronephrosis Open a glossary item) unless this has been treated
  • Have had both your hips replaced
  • Have inflammatory bowel disease
  • Have had a heart attack in the last 12 months or have certain other heart problems
  • Have any other condition that the trial doctors think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

The trial is in 2 parts. In the 1st part, people join 1 of 3 groups. The group you are in will depend on when you join the trial. Neither you nor your doctor can choose which group you are in.

  • People in group 1 have cetuximab and the chemotherapy drugs mitomycin C and 5FU at the same time as radiotherapy
  • People in group 2 have cetuximab and a chemotherapy drug called cisplatin at the same time as radiotherapy
  • People in group 3 have cetuximab and a higher dose of cisplatin at the same time as radiotherapy

In the 2nd part of the trial, everybody has cetuximab, mitomycin C and 5FU at the same time as radiotherapy. The treatment takes about 8 weeks all together. You have

  • Radiotherapy every day from Monday to Friday for just over 6 weeks
  • Cetuximab through a drip into a vein a week before starting radiotherapy and then once a week for the next 7 weeks. This takes 2 hours the first time and then 1 hour in the following weeks
  • Mitomycin C and 5FU in the 1st week of radiotherapy and 5FU alone in the 4th week. You have mitomycin C as an injection into a vein. You have the 5FU through a drip into a vein over 5 days each time

You will have a central line put in before you start treatment. This means you can have the 5FU via a small portable pump that you carry around and you don’t have to stay in hospital.

The trial team will ask you to fill out some questionnaires when you join the trial, at the end of your treatment and at each of your follow up visits. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study. You don’t have to take part in the quality of life study if you don’t want to. You can still take part in the trial.

The trial team may also ask you to agree to them using any tissue samples (biopsies) you had taken during either a cystoscopy or surgery. They will also ask if you will give some extra blood samples and also some urine samples. These will be used for research into improving bladder cancer treatments. If you agree to give these additional samples the trial team will explain what is involved. You do not have to give these samples if you don’t want to. You can still take part in the trial.

 

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • CT scan or MRI scan
  • Blood tests
  • Urine tests
  • A test to look at the inside of your bladder (a rigid cystoscopy)

You go to hospital every day for just over 6 weeks to have radiotherapy. On some days you also have cetuximab or chemotherapy (or both).

You have regular blood tests during treatment. When you finish treatment you see the trial team and have more blood tests about a month later.

About 3 months after you finish treatment, you see the trial team again and have a physical examination, blood tests, a test to look at the inside of your bladder (a cystoscopy) and a CT or MRI scan. You then have follow up visits 6, 10 and 16 months after finishing treatment. You have a physical examination, a scan and a cystoscopy each time.

Side effects

The common side effects of cetuximab include

  • Skin reactions including a rash or itchy skin
  • Low magnesium levels in your blood which can make you feel weak or confused
  • Fever
  • Chills
  • Dizziness
  • Shortness of breath
  • Changes to your liver
  • Inflammation of the lining of your intestine, mouth and nose which can cause nosebleeds

The common side effects of mitomycin C and 5FU include

We have more information about the side effects of bladder radiotherapy.

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

Professor Nick James

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Merck Serono UK
NIHR Clinical Research Network: Cancer
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/09/021.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

3872

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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