
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at how well a drug called temsirolimus (Torisel) works with cisplatin and gemcitabine chemotherapy to treat cancer that has spread into surrounding tissue (locally advanced), or to another part of the body.
Cancer Research UK supports this trial.
The urinary system filters waste products from the blood and makes urine. Transitional cells (also called the urothelial cells) line the
So you can get transitional cell cancer in the kidney, bladder, ureters or urethra.
Doctors often treat advanced transitional cell cancer with chemotherapy. One combination of chemotherapy drugs they use is cisplatin and gemcitabine.
Temsirolimus is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The aims of this trial are to find out
There are 2 parts to this trial.
You may be able to enter the 1st part of the trial if you have a that has spread into the surrounding tissue (locally advanced) and can't be cured or has spread to another part of your body. And there is no
or gemcitabine and cisplatin is an accepted standard treatment (your doctor can tell you).
You may be able to enter the 2nd part of this trial if you
You cannot enter this trial if
This is trial is in 2 stages. The first stage is a phase 1 trial. It will recruit 42 people. In this stage the researchers want to find out the best dose of temsirolimus to give with cisplatin and gemcitabine.
The first patients taking part will have the lowest dose of temsirolimus. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
The second stage is a phase 2 trial. It will recruit another 63 people.
Everyone will have temsirolimus, cisplatin and gemcitabine. You have them as an injection into a vein every 3 weeks. Each 3 week period is called a cycle of treatment. You can have up to 6 cycles.
If you agree to take part in this study, the researchers will ask for some extra blood samples and a piece of tissue taken from when you had surgery or a . They will use these samples to find out more about how the combination of temsirolimus, cisplatin and gemcitabine work in your body. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.
You see the doctor and have some tests before taking part in this trial. These tests include
When you have treatment your doctor may suggest you stay in hospital for 1 or 2 nights.
During treatment you see the doctor each week for blood tests. You have a CT scan before your 4th cycle of treatment, at the end of treatment, then after 6 months and 12 months.
After treatment your doctor will talk to you about how often they want to see you.
The most common side effects of gemcitabine and cisplatin are
The most common side effects of temsirolimus are
Your doctor will talk to you about possible side effects before you agree to take part in this trial.
We have more information on gemcitabine, cisplatin and temsirolimus.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr John Chester
Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
Pfizer
Wales Clinical Trials Unit (WCTU)
This is Cancer Research UK trial number is CRUK/08/015.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.