A trial looking at standard treatment with or without paclitaxel for ovarian cancer that has come back (ICON 4)

Cancer type:

Ovarian cancer




Phase 3

This trial compared standard treatment alone using ‘platinum’ chemotherapy such as carboplatin or cisplatin with standard treatment and paclitaxel (Taxol) for ovarian cancer. It recruited women whose cancer had come back (recurred) after treatment.

More about this trial

Doctors usually treat ovarian cancer with surgery and chemotherapy. But sometimes ovarian cancer starts to grow again after it is first treated. If this happens, it can be more difficult to treat successfully.

The aims of this trial were to find out

  • If standard treatment and paclitaxel is better than standard treatment alone for ovarian cancer that has come back
  • More about the side effects and quality of life

Summary of results

The trial team found that standard treatment together with paclitaxel is a useful treatment for ovarian cancer that has come back after it was first treated.

The trial recruited 802 women with ovarian cancer that had come back at least 6 months after first chemotherapy treatment.

  • Half had standard treatment with ‘platinum’ chemotherapy such as carboplatin or cisplatin
  • Half had standard treatment and paclitaxel

The researchers analysed the results in 2003. They found the cancer went away or shrank in more women who had paclitaxel with standard treatment than in women who had standard treatment alone.

They also found that more women lived for longer than 2 years after treatment in the paclitaxel group (57%) than in the group who had standard treatment alone (50%).

Women in the paclitaxel group had more hair loss and problems with numbness or tingling in their hands or feet (peripheral neuropathy). But fewer problems with a drop in blood counts than the women in the standard treatment group. Overall, the researchers found no difference in quality of life between the 2 different treatment groups.

The researchers concluded that women whose ovarian cancer comes back more than 6 months after first treatment could benefit from further standard treatment and paclitaxel. This applies even if they had paclitaxel as part of their first treatment.

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) and 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

Prof Jonathan Ledermann

Supported by

Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer

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Freephone 0808 800 4040

Last review date

CRUK internal database number:


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:

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