A trial of cabazitaxel for transitional cell bladder cancer that has spread (CAB B1)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bladder cancer

Kidney cancer

Transitional cell cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a chemotherapy drug called cabazitaxel for transitional cell cancer of the bladder or urinary system. It is for people who have cancer that has spread and has got worse despite having chemotherapy with a platinum drug Open a glossary item .

More about this trial

Transitional cell cancer (TCC) is the most common type of bladder cancer. Transitional cells (also called urothelial cells) line the urinary system so you can also get TCC in the kidney, ureters or urethra Open a glossary item .

If transitional cell cancer has spread into surrounding tissue or to another part of your body, doctors usually treat it with chemotherapy. They often use platinum chemotherapy drugs such as cisplatin or carboplatin. But the cancer can come back or get worse after having this type of chemotherapy. If this happens, you may have more chemotherapy. But researchers are looking for new treatments to help people in this situation.

In this trial, they are looking at a chemotherapy drug called cabazitaxel, which is already used to treat other types of cancer such as prostate cancer. The aim of the trial is to see if cabazitaxel helps people with transitional cell cancer that has spread and has got worse despite having platinum chemotherapy.

Who can enter

You may be able to enter this trial if

You have transitional cell cancer of the bladder or urinary system that has spread into surrounding tissue or to another part of your body
Your cancer has started to get worse since finishing chemotherapy that included a platinum drug
Your cancer can be measured on a scan
You have satisfactory blood test results
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old
Your are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord (central nervous system)
Have already had a taxane chemotherapy drug
Have nerve damage in your hands or feet (peripheral neuropathy), unless this is mild
Have had surgery or any other cancer treatment in the last 4 weeks
Have had another type of cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer or any other cancer that was successfully treated and is considered cured
Have had inflammatory bowel disease or a blockage in your bowel (bowel obstruction)
Have had a heart attack in the last 6 months, or have certain other heart problems – the trial team can advise you about this
Have any other serious medical condition
Need to take medication that can affect body proteins called cytochrome P enzymes – your doctor can advise you about this
Are known to be very sensitive to certain chemotherapy drugs – the trial doctors can advise you about this
Are pregnant or breastfeeding

Trial design

This phase 2 trial aims to recruit 96 people. It 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 one group have cabazitaxel through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. As long as you don’t have bad side effects, you can have up to 6 cycles of treatment.

People in the other group have whatever treatment their doctor thinks would be best to relieve their symptoms. This is called best supportive care Open a glossary item . It may include having other chemotherapy drugs, but not cabazitaxel.

CAB B1 trial diagram

The trial team will ask you to fill out a questionnaire before you start treatment, every 3 weeks during your treatment and when you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
CT scan or MRI scan
Bone scan
Heart trace (ECG )

If you are in the group having cabazitaxel, you go to hospital once every 3 weeks to have treatment. It takes about an hour each time.

If you are in the other group, the number of hospital visits you have will depend on your treatment. Your doctor will explain this to you.

Everybody taking part has a CT scan or MRI scan after about 9 weeks of treatment.

When you finish treatment, you see the trial team 3 weeks later. You have a physical examination, blood tests and another CT or MRI scan. You then see them every 3 months for up to 2 years.

Side effects

The side effects of cabazitaxel include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Diarrhoea
Poor appetite and weight loss
Tiredness (fatigue)
Sore mouth
Bone pain and muscle weakness
Hair thinning
Skin changes, such as a rash
Swelling due to fluid retention
Redness or soreness on the palms of your hands or soles of your feet
Numbness and tingling in your hands and feet (peripheral neuropathy)
High temperature (fever)
Low blood pressure
Change to the way your liver works
Red or sore eyes
Dehydration