“I think it’s really important that people keep signing up to these type of trials to push research forward.”
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.
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
- Centre of the kidney (renal pelvis)
- Tube that takes urine from the kidney to the bladder (ureter)
- Tube that drains urine from the bladder and out of the body (
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 situof 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
- 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
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.
You will see the doctors and have some tests before you start treatment. The tests include
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.
The most common side effects of pazopanib are
The most common side effects of paclitaxel are
- Allergic reactions
- Hair loss
- Aching joints or muscles
- Tiredness (fatigue)
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
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.
Dr Robert J Jones
Prof Thomas Powles
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
University of Glasgow
This is Cancer Research UK trial number CRUKE/11/021