A trial looking at erlotinib after standard treatment for ovarian cancer (OV07/EORTC 55041)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 3

This trial looked at erlotinib (Tarceva) for women who had finished standard treatment for ovarian cancer.

Doctors usually treat ovarian cancer, with surgery and chemotherapy. This is standard treatment. But sometimes the cancer comes back after standard treatment.

Erlotinib is a type of biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Doctors hoped erlotinib would be able to stop or slow down the growth of ovarian cancer.

The aims of this trial were

  • To find out if adding erlotinib to standard treatment helped to stop or delay ovarian cancer coming back
  • To learn more about the side effects of erlotinib for ovarian cancer

Summary of results

The trial team found that having erlotinib after the standard treatment for ovarian cancer didn’t help to stop it coming back.

This was an international phase 3 trial. It was a randomised trial. Everyone had the standard treatment before they were randomly put into 1 of 2 groups. The 2 groups were those who had erlotinib after standard treatment and those who didn’t.

Of the 835 women recruited, the researchers were able to look at the results of 831.

The researchers used 2 methods to see if the cancer had started to grow again. The first was an increase in a substance, called CA125 Open a glossary item, in the blood. The second was measuring the cancer on a scan.

The researchers monitored the women for an average of just over 4 years. For women who had an increase in their CA125, they found that

  • 8 out of every 100 (8%) had erlotinib
  • 11 out of every 100 (11%) didn’t have erlotinib

For those women whose cancer was bigger on a scan

  • 33 out of every 100 (33%) had erlotinib
  • 31 out of every 100 (31%) didn’t have erlotinib

For those women who had an increase in their CA125 and their scan showed their cancer was getting bigger

  • 7 out of every 100 (7%) had erlotinib
  • 6 out of every 100 (6%) didn’t have erlotinib

The worst side effects reported from those having erlotinib were diarrhoea and a skin rash. Of the women who had erlotinib, 25 out of every 100 (25%) stopped taking it because of the side effects.

The trial team concluded that having erlotinib after standard treatment didn’t delay or stop ovarian cancer coming back.  

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) but may not have been published in a medical journal.  The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Marcia Hall

Supported by

Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Roche

Other information

The Cancer Research UK number for this trial was CRUKE/05/025.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

715

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think