A study looking at a new chemotherapy combination to treat transitional cell cancer of the urinary system that has spread (GO 80)

Please note this trial is no longer recruiting patients.

This study is to see how well the chemotherapy drug gemcitabine works with oxaliplatin, instead of cisplatin. The urinary system filters waste products from the blood and makes urine. It is lined with stretchy cells called transitional (or ‘urothelial’) cells. This study is looking at cancers of the transitional cells (‘TCC’) at the centre of each kidney (renal pelvis), the bladder and the tubes that link these (the ureters).

Doctors usually treat these cancers with surgery. If the cancer spreads you may have chemotherapy. Doctors usually use cisplatin, with gemcitabine or a combination called MVAC. Many people with cancer of the urinary system already have kidney problems (‘impaired renal function’). And cisplatin can cause kidney damage. So doctors do not want to give cisplatin and risk making these problems worse.

Oxaliplatin is from the same family as cisplatin, but appears not to damage the kidneys. This study will use oxaliplatin and gemcitabine to treat people with TCC who either have kidney problems, or have had cisplatin but need more chemotherapy. The aims of this study are to

See how well gemcitabine and oxaliplatin chemotherapy work to treat transitional cell cancer of the urinary system
Learn more about the side effects
Find out more about how this cancer and treatment affect your quality of life

Recruitment

Start 01/06/2005

End 31/01/2011

Phase

Phase 2

Who can enter

You can enter this study if you

Have transitional cell cancer that has spread from where it started in either the centre of the kidney (renal pelvis), the ureters or the bladder
Have kidneys that cannot clean your blood properly (you have ‘poor renal function’) - you can check this with your doctor OR
Have already had cisplatin chemotherapy, but your cancer has continued to grow
Have other satisfactory blood tests
Are well enough to take part (performance status 0 or 1)
Are at least 16 years old

You cannot enter this study if you

Have already had gemcitabine or oxaliplatin chemotherapy
Are having treatment in another clinical trial

Trial design

This study will recruit 40 people into 2 groups. If your kidneys cannot clean your blood properly you will be in group 1. If you have already had cisplatin chemotherapy you will be in group 2. These groups simply help separate the results for the researchers – both will have exactly the same treatment. You will have a course of gemcitabine and oxaliplatin chemotherapy, and fill out some quality of life questionnaires.

You will have your chemotherapy in 3 week cycles of treatment. You will have up to 4 cycles of treatment. The number you have will depend on how well the treatment helps your cancer.

On day 1 of your treatment, you will have gemcitabine and oxaliplatin chemotherapy through a drip into a vein. This will take about 2 hours. One week later (day 8) you will have gemcitabine again, over about an hour and a half. You will need to stay at the hospital for half an hour after your treatment each time to make sure you feel well enough to go home. You then have a week with no treatment.

You will also have medication for any side effects, for example to prevent sickness.

Hospital visits

Before you start the study you will see the doctor and have some tests. These tests include

Blood test
Chest X-ray (if you have not had one in the last 3 months)
CT scan of your tummy area (abdomen) and the area between your hips (pelvis), if you have not had one in the last 4 weeks
Heart trace (ECG)
Performance status

You will also fill out a questionnaire before you start each treatment and when you finish the study. The questionnaire will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study.

On the first day of each cycle of treatment, you will see the doctor and have a blood test.

You will also have a CT scan after every second cycle of treatment.

At the end of the study you will see the doctor and have another blood test. After the study you will see the study team each month for the rest of your life.

Side effects

Side effects of oxaliplatin and gemcitabine can include

Numbness and tingling in your hands and feet (peripheral neuropathy)
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick (nausea and vomiting)
Diarrhoea
Hair loss
Tiredness and weakness
Sore mouth
Taste changes
Loss of appetite
Feeling of tightening around the voice box (this is rare and passes after a few minutes)
Allergic reaction (rash, itching and swelling)
Short term changes to the way your liver and kidneys work
Skin rash, itching or swelling
Flu like symptoms
Breathlessness

Oxaliplatin is already used to treat other cancers. But it hasn’t been used in this way before. So there may be side effects or risks that we do not know about yet. This is one of the reasons for this study.

You can find out more about the side effects of oxaliplatin and gemcitabine on CancerHelp UK.