A trial looking at the use of the CA 125 blood test to help monitor women with advanced ovarian cancer

Please note this trial is no longer recruiting patients.

This trial will look at whether the CA 125 blood test is a reliable way to measure if treatment for ovarian cancer, fallopian tube cancer or primary peritoneal cancer is working or not.

If you have advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer, you may have cancer treatments such as chemotherapy. But there is a risk that your cancer will come back (recur) or continue to grow despite this treatment. Further treatment may help to stop or control the growth of your cancer.

Doctors want to find a reliable way to find out if treatments are having any effect on the cancer. A test called the CA 125 blood test is already used to monitor a woman’s ovarian cancer and treatment. CA 125 is a ‘tumour marker’. This a chemical that is given off by some cancer cells and can be measured by a blood test. If a woman has a raised CA 125 level when diagnosed with ovarian cancer, it may be possible to follow the level of CA 125 in the blood to get an idea of how well treatment is working. But this test is not completely reliable.

The researchers of this trial are looking more closely at CA 125. They will try to find out whether changes in the levels of this chemical will reliably show whether treatment is working. The treatment used in this trial is tamoxifen, a type of hormone therapy. Tamoxifen is used to treat some women with ovarian cancer because earlier trials have shown that it has some benefit in slowing the growth of the cancer.

Recruitment

Start 01/12/2003

End 27/11/2011

Phase

Phase 2

Who can enter

You can enter this trial if

Have ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Your cancer is advanced
Your cancer has come back (relapse) and you have had chemotherapy to treat your first, second, third or fourth relapse
Your CA 125 blood tests were raised before starting treatment for recurrent cancer and your CA 125 has significantly fallen as a result of your treatment - your consultant will be able to tell you if this applies to you
You are post menopausal
You are well enough to take part in this trial
You are a patient at one of the hospitals taking part in this trial

You cannot enter this trial if you

Have never had a raised CA125 blood test
Are pregnant, breastfeeding or premenopausal
Are having hormone therapy (apart from hormone replacement therapy, HRT)

Trial design

This trial aims to recruit about 200 women with advanced ovarian cancer. All women will have CA 125 blood tests and may have treatment with tamoxifen.

Hospital visits

If you take part in this trial, you will have blood tests every month to measure CA 125 levels in your blood . If your CA 125 rises, you will be asked to have the blood test every 2 weeks. This is so that the researchers can get a good idea of how quickly the CA 125 increases.

If the CA 125 reaches a certain level, you will start treatment with tamoxifen. You will have this as a tablet once a day.

Before you start tamoxifen, you will have a CT scan of your abdomen and pelvis and a chest X-ray. During treatment, you will have these tests every 3 months.

While you are having tamoxifen you will see a doctor every month. They will examine you and ask you whether you are having any symptoms. You will continue to have blood tests every 2 weeks.

If the scans show that your cancer has continued to grow, or you are unwell, your tamoxifen will be stopped. Your consultant will discuss further treatment with you.

Side effects

All treatments have side effects. Many women who have tamoxifen have mild side effects, or none at all. In women who do have side effects, the most common include