A trial looking at ZD4054 for prostate cancer that has spread to the bones (4054IL/0006)

Please note this trial is no longer recruiting patients.

This trial is comparing different doses of ZD4054 for prostate cancer that has spread to the bones.

Doctors usually treat prostate cancer with surgery, radiotherapy or hormone therapy. But sometimes the cancer continues to grow, and when this happens it can be more difficult to treat.

Endothelin 1 (ET1) is a growth factor made by the body. It attaches to receptors on prostate cancer cells called endothelin A receptors. When ET1 binds to the receptor, it encourages the cell to grow and divide.

ZD4054 is a new drug. It is called an ‘endothelin A receptor antagonist’. This means it stops ET1 attaching to the endothelin A receptor. Doctors hope that if the ET1 cannot attach to the receptor, it will not be able to tell the cell to grow and divide. But they are not sure yet how well this will work.

The aim of this trial is to find out how well ZD4054 works for prostate cancer that has spread to the bones. And to find out more about the side effects.

Recruitment

Start 23/09/2004

End 16/12/2005

Phase

Phase 2

Who can enter

You can enter this trial if you

Have stage 4 prostate cancer that has spread to the bones (bone metastases)
Have no pain or only mild pain caused by the cancer in your bones
Have had surgery or hormone therapy for your prostate cancer, but your cancer has continued to grow
Have rising PSA levels
Have satisfactory blood test results
Are well enough to take part in the trial (performance status 0 or 1)
Are at least 18 years old

You cannot enter this trial if you

Have a lot of pain caused by the cancer that has spread to your bones (bone metastases)
Have prostate cancer that has spread to your brain
Have had radiotherapy for bone metastases in the last 4 weeks
Have had chemotherapy for prostate cancer that has spread
Have had hormone therapy in the last 4 weeks
Have had internal radiotherapy in the past 3 months for cancer spread to the bones, such as strontium 89, rhenium 186 or samarium 153
Have had certain other drugs or herbal remedies in the last 2 weeks, such as carbamazapine, phenobarbitone, phenytoin, rifampicin or St John’s Wort
Have had an endothelin receptor antagonist before
Have taken part in another clinical trial in the last 4 weeks
Have heart failure, or any other serious medical condition

Trial design

This is a randomised trial. It will recruit 260 people worldwide. The people taking part are put into one of 3 groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You won’t know which group you are in either. This is called a ‘double blind’ trial.

Group 1 have ZD4054
Group 2 have a higher dose of ZD4054
Group 3 have a dummy tablet (placebo)

You will take either ZD4054 or a placebo once a day, every day. You will take it for up to 2 years as long as tests show your cancer is not growing. But if there are signs that your cancer has started to grow again, your doctor will probably decide to stop the treatment. He or she will discuss other treatment options with you.

You will fill out a questionnaire before you start treatment and then every 4 weeks while you are taking part in the trial. This will ask you how you have been feeling and about any side effects you have had. It is called a ‘quality of life’ questionnaire.

Hospital visits

You will go to the hospital for some tests before you start the trial. These include

Blood tests, including a PSA test
Urine test
Heart trace (ECG)
Bone scan
Physical examination
CT scan or MRI scan

You will have blood tests every 4 weeks, and another ECG 4 weeks after you start treatment. You will have a CT or MRI scan every 3 months, and a bone scan when you stop treatment.

ZD4054 and the placebo are tablets that you take at home once a day. You will go to the hospital every 4 weeks to see the doctors and have a blood test. But you should not need to stay in hospital overnight as a result of taking part in this trial.

You will see the trial doctors 4 weeks after you stop taking ZD4054 or the placebo. After that you will continue to see your own cancer specialist.