A trial looking at trabectedin and pegylated liposomal doxorubicin for ovarian cancer (INOVATYON)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 3

This trial looked at trabectedin and liposomal doxorubicin for recurrent ovarian cancer. 

It was for women who had:

  • ovarian cancer
  • fallopian tube cancer 
  • primary peritoneal cancer 

Doctors treat these cancers in the same way. So when we use the term ovarian cancer in this summary, we are referring to all three. 

Cancer Research UK supports this trial.

This trial was open for people to join between 2016 and 2017. The team published the results in 2020.

More about this trial

A usual treatment for ovarian cancer is surgery followed by chemotherapy. Sometimes the cancer can come back. This is called recurrent cancer. Doctors are always looking at ways to improve treatment for ovarian cancer that has come back.

When this trial was done researchers looked at having more chemotherapy. This included carboplatin and liposomal doxorubicin. This was a usual treatment option. And they compared it to trabectedin and liposomal doxorubicin.

Trabectedin is also a chemotherapy drug. Doctors knew from previous studies that it helped women whose ovarian cancer had come back. They thought that trabectedin and liposomal doxorubicin might work better. But they weren’t sure so wanted to find out more. 

In this trial, some people had carboplatin and liposomal doxorubicin. And some had trabectedin and liposomal doxorubicin. 

The main aims of the trial were to:

  • find out which treatment works best
  • learn more about the side effects 
  • see how treatment affects quality of life Open a glossary item

Summary of results

The team found that trabectedin and liposomal doxorubicin didn’t improve treatment. It didn’t increase the length of time people with recurrent ovarian cancer lived. 

Trial design
This was an international phase 3 trial. 617 people took part. 

It included people whose cancer had come back. And this happened between 6 and 12 months after finishing carboplatin.

It was a randomised trial. People were put into 1 of 2 groups:

  • 306 had carboplatin and liposomal doxorubicin (group 1)
  • 311 had trabectedin and liposomal doxorubicin (group 2)

Neither the people taking part nor their doctor chose which group they were in.

Everyone had up to 6 cycles Open a glossary item of treatment. This took up to 6 months in total.

Most people went on to have more treatment after stopping trial treatment. People in group 1 had the treatment their doctor recommended. People in group 2 had treatment that included a platinum drug.  Open a glossary item

Results
The team looked at how well treatment worked. To do this they looked at how long people lived. They found this was about 21 months for both groups. 

They also looked at how long it was before the cancer started to grow again. This was about:

  • 9 months for people who had carboplatin and liposomal doxorubicin
  • 7½ months for people who had trabectedin and liposomal doxorubicin

The team wanted to find out if trabectedin worked better for certain groups. To find this out they looked at:

  • who had a gene change in BRCA1 Open a glossary item or BRCA2 Open a glossary item in the ovarian cancer cells
  • how far the cancer had spread
  • how many treatments people had in the past
  • tissue samples (biopsies) Open a glossary item
  • further treatment 

They couldn’t identify a subgroup of people who benefited more than the others. 

The team also looked at who stopped treatment early. This happened in just under:

  • 2 out of 10 people (28%) who had carboplatin and liposomal doxorubicin
  • 5 out of 10 people (46%) who trabectedin and liposomal doxorubicin

The main reason was because treatment had stopped working. Other reasons included:

  • having bad side effects
  • people choosing not to continue with treatment 

Quality of life
The team found that people who had carboplatin and liposomal doxorubicin said they had a better quality of life

Side effects
Most people had side effects. The team looked at who had bad to severe side effects. People who had trabectedin and liposomal doxorubicin had worse side effects. 

The most common side effects were: 

  • a drop in blood cells causing an increased risk of infection, bruising or bleeding or breathless and looking pale 
  • digestive system Open a glossary item  side effects such as tummy (abdominal) pain, blocked intestine, feeling or being sick, sore mouth, indigestion, diarrhoea or constipation
  • liver changes

A common side effect for both groups was tingling or numbness in the arms. How bad this was ranged from mild to moderate. 

Conclusion
The trial team didn’t find that trabectedin and liposomal doxorubicin improved treatment. It didn’t increase the length of time that people with ovarian cancer lived.

They did find that the length of time people lived was similar between the 2 treatment groups. The team say that trabectedin could be a treatment option for some. It might be useful for people recovering from the side effects that platinum drugs can cause.

All trial results help doctors and researchers understand more about different cancers. And the best way to treat them. 

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 Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. 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 Ana Montes

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Mario Negri Gynecologic Oncology Group (MaNGO)
National Cancer Research Institute (NCRI)
Pharma Mar

Other information

This is Cancer Research UK trial number CRUK/15/009

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14292

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

Rate this page:

Currently rated: 3.5 out of 5 based on 4 votes
Thank you!
We've recently made some changes to the site, tell us what you think