A trial looking at eribulin mesylate for advanced bladder cancer

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

Cancer type:

Bladder cancer

Transitional cell cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at combining a chemotherapy drug called eribulin mesylate with gemcitabine and cisplatin chemotherapy. It is for people who have bladder cancer or cancer of the cells lining the urinary tract (urothelium Open a glossary item ) that has spread to the nearby tissue (locally advanced ) or has spread to another part of the body.

Doctors often treat advanced bladder cancer with chemotherapy or radiotherapy. Gemcitabine and cisplatin is one of the combinations of chemotherapy drugs that doctors use.

Eribulin mesylate is a chemotherapy drug that’s not been used for bladder cancer before. The researchers think that combining eribulin mesylate with gemcitabine and cisplatin may be better than gemcitabine and cisplatin alone.

The aim of this trial is to compare the combination of eribulin mesylate, gemcitabine and cisplatin with gemcitabine and cisplatin to find

Which combination works best to treat advanced bladder cancer
How safe the combination of eribulin mesylate, gemcitabine and cisplatin is

Who can enter

You may be able to enter this trial if you

Have transitional cell cancer of the tubes that join the kidneys to the bladder (ureters) or bladder or prostate or tube that carries urine from the bladder to outside the body (urethra) that has spread into the surrounding tissue or spread to another part of the body
Have at least one area of cancer that can be measured on a scan
Have satisfactory blood tests results
Open your bowels at least 3 times a week and are willing to keep a diary of when you go to the toilet to open your bowels– you may join if you are taking laxatives
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
Are willing to use reliable contraception during treatment and for 3 months after treatment if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have bladder cancer that has spread to your brain – you may be able to join if the cancer spread has been treated, you have no symptoms and you have been off steroids for the past 4 weeks
Have already had epothilone, ixabepilone, patupilone, vinflunine or halichondrin B – your doctor can advise about this
Have had an anti cancer treatment (including radiotherapy) in the last month
Have had treatment as part of another clinical trial in the last month
Are still having side effects from anti cancer treatment – you may be able to join if you have only mild nerve damage (peripheral neuropathy ) or hair loss
Have had radiotherapy to the area between your hips (pelvis)
Have had another cancer apart from non melanoma skin cancer, in situ carcinoma of the cervix, prostate cancer or superficial bladder cancer that have been successfully treated or any other solid tumour that has been successfully treated and there has been no sign of it for at least 3 years
May need to have radiotherapy to control your symptoms while taking part in this trial
Are taking medication that affects your immune system
Have had a heart attack in the last 6 months or have another serious heart problem
Have moderate to severe constipation
Are HIV, hepatitis B or hepatitis C positive
Have a problem with your digestive system that could increase your risk of bleeding or causing a wound if you take the study drug – your doctor can advise about this
Have any other medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It is an international trial and will recruit about 80 people from different countries around the world.

It is a randomised trial. People taking part will be put into 1of 2 treatment groups. Neither you nor your doctor can choose which group you are in.

People in group 1 will have eribulin mesylate, gemcitabine and cisplatin.

People in group 2 will have gemcitabine and cisplatin.

You have eribulin mesylate as an injection into a vein. You have it once a week for 2 weeks and then a week without treatment. Each 3 week period is called a cycle of treatment.

You have gemcitabine and cisplatin through a drip into a vein. You have gemcitabine once a week for 2 weeks and then a week without treatment. You have cisplatin on the first day of each 3 week treatment cycle.

You can have up to 6 cycles of treatment.

People in group 1 may be able to continue taking eribulin mesylate after stopping gemcitabine and cisplatin. Your doctor will talk to you about this.

You have a diary to record when you go to the toilet to open your bowels. Because it is important you don’t get constipated while on treatment.

The researchers will also ask your permission to take a small piece of the tumour tissue removed when you had your biopsy or surgery, and some extra blood samples. They will use these to find out more about how the treatment works. You don’t have to agree to this if you don’t want. You can still take part in the main trial.