A trial to see how chemotherapy affects bladder cancer cells (ADVICE trial)

Who can enter

You can enter this trial if you

• Have transitional cell, invasive bladder cancer
• Are well enough to take part in this trial (performance status 0, 1 or 2)
• Have satisfactory blood and urine test results
• Are over 18 years old
• Are willing to use reliable contraception while you are taking part in this trial if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

• Have bladder cancer that has spread to another part of your body (metastasised)
• Have had radiotherapy or chemotherapy before, unless it was for basal cell skin cancer
• Are still recovering from an operation you have had
• Have any other serious illness or medical condition which the researchers think will affect your treatment or the results of this trial
• Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 50 people to begin with. If all goes well, it will go on to recruit more. Everyone taking part will have both gemcitabine and cisplatin chemotherapy.

You have gemcitabine and cisplatin twice in 3 weeks. Each 3 weeks of treatment is one cycle. You will have 4 cycles over about 3 months (12 weeks). You have both drugs (and some extra fluid) through a drip into a vein in your arm. This will take several hours each time.

After 4 cycles of treatment the doctors will look inside your bladder using a thin tube with a camera on the end. This is called a cystoscopy. During the cystoscopy, the doctors will take several small samples (biopsies) from your bladder. They will also take a blood sample.

They hope that when they look at the genetic material and the proteins in the cancer cells and blood samples, they will be able to find out more about bladder cancer.

After the cystoscopy you will either have

• Surgery to remove your bladder cancer, or
• Radiotherapy alone or chemotherapy and radiotherapy at the same time (chemoradiation), maybe as part of the BC2001 trial or another clinical trial

Hospital visits

Before you join the trial you will see a doctor and have some tests. The tests include

• Physical examination
• Blood and urine tests
• Chest X-ray
• CT scan of the stomach and pelvic area

You will have blood tests, urine tests and a physical examination each time you have treatment. You will have chemotherapy as an outpatient, so you won’t have to stay in hospital as part of this trial.

After 4 cycles of treatment, you will have a CT scan and a cystoscopy. You will have a general anaesthetic when you have the cystoscopy, but you will be able to go home later the same day.

You will go to the hospital and see the doctors every 6 weeks for the first 3 months, then every 3 months after that. You will have a physical examination and blood tests at each visit. You will have a CT scan every 3 months for the first year, and then every 6 months after that.

Side effects

As with all treatments, gemcitabine and cisplatin have some side effects.

The most common side effects of are

• A drop in blood cells causing increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
• Feeling or being sick
• Flu like symptoms
• Tiredness (fatigue)
• Skin rash
• Swelling in your hands and feet with gemcitabine
• Possible kidney damage with cisplatin (you will have plenty of fluids to stop this from happening)

There is more information about the side effects of gemcitabine and cisplatin on CancerHelp UK.