A trial looking at pazopanib for transitional cell urothelial tract cancer (PLUTO)

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

Cancer type:

Bladder cancer
Kidney cancer
Transitional cell cancer




Phase 2

This trial is looking at pazopanib for transitional cell cancer of the urinary tract that did not go away or has come back after treatment with chemotherapy. The trial is supported by Cancer Research UK.

The urinary tract includes the

The lining of the urinary tract is called the urothelium. It is made up of cells called transitional cells. Cancer that starts in these cells is called transitional cell cancer of the urothelial tract.

Doctors can use paclitaxel to treat cancer of the urothelial tract that did not go away or has come back after treatment. But unfortunately it doesn’t always work very well.

Doctors know that pazopanib can help people with kidney cancer and they want to find out if it can help people with urothelial cancer.

Pazopanib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short). TKIs block tyrosine kinase, which is a chemical messenger that sends messages telling cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

The aims of this study are to find out

  • If pazopanib is better at treating urothelial cancer that has come back or not gone away than paclitaxel
  • About the side effects

Who can enter

You may be able to enter this trial if you

  • Have transitional cell cancer of the urothelial tract that has spread into surrounding body tissue or to another part of the body
  • Have had cisplatin or carboplatin chemotherapy in the past
  • Have cancer that can be measured on a CT scan
  • Have satisfactory blood test results
  • Are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
  • Are willing to use reliable contraception during treatment and for 3 weeks afterwards if there is any chance that you or your partner could become pregnant
  • At least 18 years old

You cannot enter this trial if you

  • Have cancer in your brain or central nervous system (CNS) unless it has been successfully treated and does not cause you any problems
  • Have had radiotherapy, surgery or tumour embolisation in the last 2 weeks or chemotherapy, immunotherapy, biological therapy or treatment on a trial in the last 4 weeks
  • Have side effects from previous treatment that are still causing you problems
  • Have had major surgery in the last month, or have a wound that has not healed
  • Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or carcinoma in situ of the prostate that was successfully treated at least 5 years ago
  • Have coughed up blood in the last 2 months (about a teaspoon full or more)
  • Have had severe problems with bleeding in the last 6 months
  • Have had a blot clot in the last 6 months unless it was in your leg (DVT) and has been treated for at least 6 weeks
  • Have certain heart problems
  • Are HIV positive
  • Have any illness that dampens down your immune system
  • Have a heart trace (ECG) that has measurements above a certain level
  • Have high blood pressure that cannot be controlled by tablets
  • Have any other medical problems that the doctors think could affect you taking part
  • Have had paclitaxel or pazopanib in the past
  • Are known to be allergic to cremophor or pazopanib
  • Are pregnant or breastfeeding

Trial design

This is a randomised trial. 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.

People in group A have paclitaxel through a drip into a vein weekly for 3 weeks then a week with no treatment. Each 4 week period is called a cycle of treatment. You will have up to 6 cycles.

People in group B have pazopanib tablets. You take these daily for as long as they are helping you.

The trial team will ask you to fill out a questionnaire before you start treatment and then

  • Every 2 months for 6 months
  • Every 3 months after that, until your cancer starts to grow again

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. Researchers will also ask for extra blood and urine samples. If you do not want to give these extra samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood pressure
  • Blood tests
  • Urine tests
  • Heart trace (ECG)
  • CT scan or MRI scan

Both groups see the doctor and have blood pressure, blood and urine tests every month for 6 months. Group B has 2 more heart traces (ECG’s). After 6 months you see the research team every 6 weeks (and have tests if you are in group B) until your cancer starts to grow again.

You have CT scans or MRI scans every 3 months for 2 years, or until your cancer starts to grow again.

Everyone in the trial will see the research team and have blood tests 4 weeks after their cancer has started to grow again.

Side effects

The most common side effects of pazopanib are

The most common side effects of paclitaxel are

There is more information about paclitaxel and pazopanib in our cancer drugs section.

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 Robert J Jones
Prof Thomas Powles

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
University of Glasgow

Other information

This is Cancer Research UK trial number CRUKE/11/021

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8280

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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