A trial looking at cediranib for ovarian cancer that has come back (ICON 6)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 3

This trial looked at cediranib alongside and after chemotherapy for ovarian cancer. It was for people whose cancer had come back after having chemotherapy that included a platinum drug Open a glossary item

The trial was partly supported by Cancer Research UK. It was open for people to join between 2007 and 2011. The trial team have published several papers with results from this trial.

More about this trial

When this trial was done, doctors often used surgery followed by chemotherapy to treat newly diagnosed ovarian cancer. The chemotherapy usually included a platinum drug such as carboplatin or cisplatin

They often use more chemotherapy if the cancer comes back. Researchers wanted to find out whether cediranib and chemotherapy together would be a useful treatment for people in this situation.

Cediranib (AZD2171) is type of targeted cancer treatment called a tyrosine kinase inhibitor (TKI). It stops cancers from being able to make the new blood vessels that they need to grow.

There were 3 treatment groups in this trial. Everyone taking part had chemotherapy. Some had cediranib at the same time. And some also had cediranib on its own afterwards (maintenance treatment). 

Everyone was put into 1 of the 3 groups at random:

  • Group A had chemotherapy and a dummy drug (placebo), then more placebo 
  • Group B had chemotherapy and cediranib, then a placebo 
  • Group C had chemotherapy and cediranib, then more cediranib 

The main aims of this trial were to find out:

  • if cediranib and chemotherapy is better than chemotherapy alone for ovarian cancer that has come back
  • more about the side effects

Summary of results

The research team found that cediranib and chemotherapy may be useful for women with ovarian cancer that has come back after other treatment.

Results
A total of 456 women joined this trial. They all had cancer that had come back at least 6 months after finishing platinum chemotherapy. 

They were put into a treatment group at random. There were:

  • 118 people in group A (chemotherapy and placebo)
  • 174 people in group B (chemotherapy and cediranib, then placebo)
  • 164 people in group C (chemotherapy and cediranib, then more cediranib)

The trial team looked at the how long it was before the cancer started to grow in half the people taking part. Researchers call this median time to relapse.

They found it was:

  • 8.7 months for those in group A
  • 9.9 months for those in group B
  • 11.0 months for those in group C

They also looked at when half the people taking part had died. This is median survival. 

They found it was:

  • 29.5 months for those in group A
  • 32.0 months for those in group B
  • 34.3 months for those in group C

There is a difference in how long people lived between the groups. The difference between group A and group C is a bit bigger than between group A and group B. But it is not large enough for the researchers to say for sure that it was due to the different treatments. 

Side effects
Most people taking part had at least 1 side effect. Women who had both cediranib and chemotherapy had more side effects, compared to those who had chemotherapy alone.

Many side effects were mild or didn’t last long. These included fatigue and diarrhoea. But some people had more severe side effects. The most common of these included:

  • fatigue
  • diarrhoea
  • a drop in white blood cells
  • increased blood pressure
  • voice changes
  • a drop in thyroid hormones (hypothyroidism Open a glossary item)

Just over 1 in 10 people (12%) in group C decided to stop having cediranib maintenance treatment because of side effects they were having.

Quality of life
The people taking part filled out questionnaires before, during and after treatment. The questionnaires asked them about their quality of life and any side effects they were having.

The research team found there wasn’t much difference between the groups.

The best time to take cediranib
The team ran two sub studies as part of this trial. The first looked at whether it was better to have cediranib before or after food.

There were 45 people in this part of the trial. Half had cediranib after food to begin with, and then changed to having it before food. And half did it the other way around. 

The team measured the amount of cediranib in the blood. They found that it was higher in people who had treatment before food.

They concluded that it was best to take cediranib either 1 hour before or 2 hours after food.

The effect on the cancer’s blood supply
The second sub study looked at whether cediranib affects the blood supply to the cancer cells.

There were 47 people in this part of the trial. Half had the same dose of cediranib every day. And half started on a lower dose and gradually increased.

The people taking part had DCE-MRI scans before treatment and at 1, 2 and 4 months. These scans help show the blood supply to cancer cells.

The results showed that cediranib can affect blood supply to the cancer. And that taking the same dose of cediranib every day had the most effect.

Conclusion
The researchers think cediranib may be useful for women with ovarian cancer that has come back. But they cannot say for sure based on the results of this trial. They suggest more work is done to find out more. 

More detailed information
There is more information about this research in the references below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Cediranib in addition to chemotherapy for women with relapsed platinum sensitive ovarian cancer (ICON6): overall survival results of a phase III
randomised trial

J Ledermann and others
ESMO Open Journal, 2021. Volume 6, issue 2, article 100043.

Quality of Life With Cediranib in Relapsed Ovarian Cancer: The ICON6 Phase 3 Randomized Clinical Trial
D Stark and others
Cancer, 2017.  Volume 123, issue 14, pages 2752 - 2761.

Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial
J Ledermann and others
The Lancet, 2016. Volume 387, issue 10023, pages 1066 - 1074.

Randomised double-blind phase III trial of cediranib (AZD 2171) in relapsed platinum sensitive ovarian cancer: Results of the ICON6 trial
J Ledermann and others
NCRI Cancer Conference, 2013. Clinical Trials Showcase abstract.

A two-part Phase II study of cediranib in patients with advanced solid tumours: the effect of food on single-dose pharmacokinetics and an evaluation of safety, efficacy and imaging pharmacodynamics
C Mitchell and others
Cancer Chemotherapy and Pharmacology, 2011. Volume 68, pages 631 – 641.

Where this information comes from    
We have based this summary on the information in the articles above. These have been reviewed by independent specialists (peer reviewed Open a glossary item) and published in medical journals. We have not analysed the data ourselves. As far as we are aware, the links we list above are active and the articles are free and available to view.

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

Professor Jonathan Ledermann

Supported by

AstraZeneca
Canadian Cancer Society Research Institute
Cancer Australia
Cancer Research UK
Medical Research Council (MRC)
National Gynaecological Cancer Centre
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/07/025.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

713

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

Last reviewed:

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