A trial looking at carboplatin, gemcitabine, bevacizumab and pegylated liposomal doxorubicin for ovarian cancer (OPSROC)
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This trial looked at carboplatin, gemcitabine, bevacizumab and pegylated liposomal doxorubicin to treat recurrent ovarian cancer.
It was for women whose ovarian cancer came back (recurred) more than 6 months after initially responding to platinum chemotherapy drugs.
The trial was for women who have:
• ovarian cancer
• primary peritoneal cancer
• fallopian tube cancer
These cancers are treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all of these.
This trial was open in the UK for women to join between January 2015 and August 2015. These results were presented at a conference in 2019.
More about this trial
Doctors usually treat ovarian cancer with surgery followed by chemotherapy. One chemotherapy drug they often use is a platinum drug called carboplatin.
In this trial, the researchers looked at the drugs bevacizumab, gemcitabine and pegylated liposomal doxorubicin.
Bevacizumab (Avastin) is a targeted cancer drug called a monoclonal antibody. It seeks out cancer cells by looking for particular proteins on their surface.
Gemcitabine is a chemotherapy drug that doctors can use with carboplatin to treat ovarian cancer.
Pegylated liposomal doxorubicin is a different form of the chemotherapy drug doxorubicin. Pegylation is a way of treating drugs to change the way they behave in your body. This might help doxorubicin stay in your bloodstream longer so that more of it reaches the cancer cells.
Researchers thought that the combination of bevacizumab, carboplatin and pegylated liposomal doxorubicin may be better than carboplatin, bevacizumab and gemcitabine. They also thought the side effects might be less severe.
We knew from research that having bevacizumab with carboplatin and gemcitabine then continuing with bevacizumab only after might delay the ovarian cancer coming back.
In this trial half the women had carboplatin, bevacizumab and pegylated liposomal doxorubicin. The other half had carboplatin, bevacizumab and gemcitabine. Everyone continued to have bevacizumab only after chemotherapy.
The aims of the trial were to find out:
- which combination of drugs delayed ovarian cancer coming back the longest
- what the side effects of each combination of drugs were
- how each combination of drugs affected quality of life
Summary of results
The trial team found that bevacizumab, carboplatin and pegylated liposomal doxorubicin (CD-BEV) was better than carboplatin, bevacizumab and gemcitabine (CG-BEV).
About this trial
This was an international phase 3 trial. 682 women worldwide took part.
This included 7 women in the UK. It was open in the UK for women to join between January and August 2015.
It was a randomised trial. Everyone who took part were put into 1 of 2 treatment groups. Neither they nor their doctor chose which group they were in. The groups were:
- 337 women had CG-BEV
- 345 women had CD-BEV
Results
The researchers looked at the average length of time women were alive and had no sign of their cancer after treatment. They found that it was:
- just over 11½ months (11.7) for women who had CG-BEV
- over 13 months (13.3) for women who had CD-BEV
They also looked at the average overall time the women lived after their treatment. They found it was:
- just under 28 months (27.9) for women who had CG-BEV
- 32 months for women who had CD-BEV
Quality of life
They found that overall the women who had CD-BEV reported having a better
than women who had CG-BEV.
Side effects
Of the 329 women who had CG-BEV, 319 (97%) had side effects.
Of the 332 women who had CD-BEV, 327 (98.5%) had side effects.
Conclusion
The trial team concluded that CD-BEV worked better than CG-BEV for women with ovarian cancer that had come back after having a platinum drug. And this is a new treatment option for these women.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) but may not have been published in a medical journal. The figures we quote above were provided by the research 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.
Chief Investigator
Dr Ros Glasspool
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche
NHS Greater Glasgow and Clyde
AGO study group
Other information
This is Cancer Research UK trial number CRUKE/13/027.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
