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:
Status:
Phase:
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 
.
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 .
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 . It may include having other chemotherapy drugs, but not cabazitaxel.
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
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
If you are in the best supportive care group, your doctor will explain the possible side effects of any treatment.
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 Anjali Zarkar
Supported by
Sanofi
University Hospital Birmingham NHS Foundation Trust
University of Warwick
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
