A trial looking at lapatinib for people with bladder cancer that has spread (LaMB)

This trial is looking at lapatinib (Tyverb) for people with advanced bladder cancer.

Doctors usually treat advanced bladder cancer with chemotherapy. But at some point, the cancer may start to grow again and may spread to other parts of the body. Doctors are looking at ways to delay the cancer from growing again.

Lapatinib is a type of biological therapy called a tyrosine kinase inhibitor (TKI). Tyrosine kinsases are proteins that stimulate cancer cells to grow. Lapatinib blocks two of these proteins from working. The first is called HER1 (also known as epidermal growth factor receptor or EGFR). The second is called HER2/neu receptor. Many bladder cancers have too many of one or both of these receptors. If your cancer is one of these, then you may be able to take part.

Doctors hope that by giving lapatinib after chemotherapy they may be able to slow down the growth of the cancer. But they don’t know yet if it will be helpful. As all treatments have side effects, it is important that people do not have treatments that don’t work. This trial is comparing lapatinib to a dummy drug (placebo).

The aim of this trial is to

Find out if lapatinib can stop or slow down the growth of advanced bladder cancer
Learn more about the side effects of treatment

Recruitment

Start 27/01/2009

End 01/04/2013

Phase

Phase 2/3

Who can enter

You can enter this trial if

You have advanced stage transitional cell cancer (TCC) of the lining of the urinary system (urothelium)
Your cancer cells are HER1 or HER2 receptor positive (the researchers will check this first)
You have had between 4 and 8 cycles of chemotherapy and your cancer has shrunk or stayed the same
You can start lapatinib within 10 weeks of finishing chemotherapy
You are well enough to take part (performance status 0,1, 2 or 3)
You are at least 18 years old
You are willing to use reliable contraception if there is any chance you or your partner could become pregnant

You cannot enter this trial if

Your cancer continued to grow while having chemotherapy
You are due to have surgery or radiotherapy after chemotherapy to treat your cancer (you can still take part if you are due to have palliative radiotherapy to treat symptoms only)
You have a medical condition affecting your liver, gallbladder or bile ducts - if you have cancer that has spread to the liver, gallstones that aren’t causing symptoms, a harmless build up of bilirubin in the blood (Gilbert’s syndrome), or stable long term liver disease, you may still be able to take part
You have any uncontrolled heart problems, such as angina, high blood pressure or an abnormal heart rhythm (arrhythmia), or you have had a heart attack
You have any other medical conditions that stop you from taking part
You have had treatment with a drug that works on HER1 or HER2 receptors before
You have had any other cancer apart from an early stage cancer that has been treated and cured
Are pregnant or breastfeeding

Trial design

To be able to take part in this trial, your doctor needs to find out whether your bladder cancer cells have too many HER1 or HER2 receptors, by testing the tissue sample taken when you were first diagnosed. If your cancer is HER1 or HER2 receptor positive you will be invited to take part in the main part of the trial.

This trial will recruit 204 people in total. It is a randomised trial. You will be put into one of two treatment groups by a computer. Neither you nor your doctor will be able to choose which group you are in, or will be told which group you are in. This is called a double blind trial.

One group will take lapatinib tablets and the other will take dummy tablets (placebo).

You will take 6 tablets once a day, at least one hour before or after food.

During treatment you will have some tests. If the tests show treatment is helping, you will continue with it for as long as it is working and you don't have serious side effects. If the tests show it is not helping, your doctor will decide to stop treatment. They will then discuss other options with you.

You will fill out a questionnaire before you start treatment and every 4 weeks during treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life questionnaire.

Before and during your treatment your doctors will ask if they can take an extra blood sample. This is for future research. Doctors hope that in future they will be able to match patients to specific treatments for bladder cancer. If you do not wish to do this, you do not have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Heart trace (ECG)
A test of how well your heart is working - either an echocardiogram) or a MUGA scan
CT scan, MRI scan or ultrasound

Once you start your treatment, you go to the hospital every 4 weeks. Your doctors will take blood tests and ask how you have been feeling. You will also have a CT, MRI or ultrasound every 12 weeks, and within 4 weeks of finishing treatment.