A trial looking at cisplatin, gemcitabine and temsirolimus to treat cancer that has spread (ToTem)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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.
More about this trial
The urinary system filters waste products from the blood and makes urine. Transitional cells (also called the urothelial cells) line the
- Centre of the kidney (renal pelvis)
- Tubes that takes urine from the kidney to the bladder (ureters)
- Bladder
- Tube that drains urine from the bladder and out of the body (
urethra 
)
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
- How well the combination of temsirolimus, cisplatin and gemcitabine works in treating advanced transitional cell cancer
- How safe the combination is
- What the side effects of this drug combination are
- What is the best dose of this combination to give
Who can enter
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
- Have transitional cell cancer of the bladder, centre of the kidney (renal pelvis) or tubes that drain urine from the kidneys to the bladder (ureters) or tube that drains urine from the bladder and out the body (urethra)
- Have transitional cell cancer that has spread to surrounding tissue or to another part of your body
- Have an area of cancer spread can be seen or measured on a scan
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception
- Are at least 16 years old
You cannot enter this trial if
- You have
leukaemia , lymphoma or myeloma - You are able to have surgery or radiotherapy with the aim to cure your cancer
- Your cancer has spread to your brain or spinal cord
- You have had a treatment that reaches your whole body (
systemic treatment ) for your transitional cell cancer. You may be able to join part 1 of the trial, if you have finished your chemotherapy at least 1 month ago. You may be able to join part 2 of the trial, if you have had no more than 4 cycles of chemotherapy and finished your treatment at least 6 months ago - You have had radiotherapy in the past month
- You had radiotherapy to more than a third of your bones that make blood cells – you can check this with your doctor
- You have had an experimental drug as part of a clinical trial in the past month
- You are having certain types of medication that thin the blood
- You are taking medications that affect the CYP3A4 enzyme
- You have had a heart attack in the past 6 months, or any other serious heart problem
- You have certain infections
- You have HIV, hepatitis B or hepatitis C
- You are pregnant or breastfeeding
Trial design
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.
Hospital visits
You see the doctor and have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - CT scan
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.
Side effects
The most common side effects of gemcitabine and cisplatin are
- Loss of appetite and taste changes
- Weight loss
- Fever
- Feeling or being sick (nausea)
- Dizziness
- Sore mouth and throat
- Heartburn and indigestion
- Constipation or diarrhoea
- Wind (flatulence)
- Tummy ache
- Dry mouth
- Change to the colour of your urine
- Dry or itchy skin, rash
- Watery eyes
- Hair loss
- Tiredness (fatigue)
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Change to the way your kidneys work
The most common side effects of temsirolimus are
- An allergic reaction causing a severe rash, flushing, chest pain, shortness of breath or low blood pressure
- A drop in blood cells
- Loss of muscle strength and weakness
- Diarrhoea
- Infections
- Skin rash
- Fever
- Nose bleeds
- Sore mouth
- Loss of appetite
- Swelling of the face and hands or feet
- Damage to your kidneys, bowels and lungs
- Changes to the amounts of sugar and fat in your blood
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.
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.
Chief Investigator
Dr John Chester
Supported by
Cancer Research UK
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
Pfizer
Wales Clinical Trials Unit (WCTU)
Other information
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
