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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 3

This trial is for women with ovarian cancer that has come back or spread elsewhere (recurrent cancer) despite treatment with platinum chemotherapy. Platinum chemotherapy includes the drugs cisplatin, carboplatin and oxaliplatin.

It is for women who have:

These cancers are treated 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. 

More about this trial

Ovarian cancer can be treated with surgery followed by chemotherapy. Often a platinum chemotherapy drug such as carboplatin is given.  

But sometimes the cancer can come back after chemotherapy. This is called recurrent cancer. 

Doctors can treat recurrent cancer with more chemotherapy. You may have carboplatin and another chemotherapy drug called pegylated liposomal doxorubicin (PLD). 

Pegylated liposomal doxorubicin is a different form of the drug doxorubicin. It is changed so it stays longer in your bloodstream. This helps to kill more cancer cells.     

But doctors are looking for new treatments to help women in this situation. In this trial, they are looking at a drug called trabectedin (also called yondelis). 

Trabectedin is also a chemotherapy drug. It is already used to treat other types of cancer. And previous studies have shown that it may be helpful to help women in this situation.          

In this trial, women have 1 of the following:

  • carboplatin and pegylated liposomal doxorubicin  
  • trabectedin and pegylated liposomal doxorubicin 

The main aims for this trial are to: 

  • find out if trabectedin and pegylated liposomal doxorubicin work better as a treatment
  • learn more about the side effects 
  • learn how well people cope with side effects
  • find out what happens to trabectedin and pegylated liposomal doxorubicin in your body (pharmacokinetics Open a glossary item

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this trial if you are a woman and all of the following apply.

  • You have epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer 
  • You have had at least 1, but no more than 2, types of platinum chemotherapy Open a glossary item (such as carboplatin) 
  • You have had at least 1 taxane Open a glossary item type of chemotherapy (such as paclitaxel)
  • You cancer has come back within 6 to 12 months after the last treatment with platinum chemotherapy
  • You have at least 1 area of cancer that can be seen on a scan or you have had a sample of tissue (a biopsy Open a glossary item) taken after your cancer came back 
  • You are well enough to be up and about for at least half of the day (performance status of 0, 1 or 2
  • You have satisfactory blood tests results
  • You are at least 18 years old
  • You are willing to use reliable contraception during treatment and for 3 months after the final dose of chemotherapy if there is any possibility you could become pregnant

You cannot join this trial if any of these apply

  • You have a non epithelial or mixed epithelial ovarian cancer (such as mullerian tumour)   
  • Your cancer came back less than 6 months or more than 12 months since your last treatment with platinum chemotherapy 
  • Your cancer has spread to your brain and is causing symptoms
  • You have a blockage in your bowel (bowel obstruction) or on any other part of your body (such as veins) 
  • You are unable to take drugs that damp down your immune system (steroids) such as dexamethasone
  • You have had trabectedin 
  • You have had doxorubicin or epirubicin (you may be able to take part if you only have had small amounts of the 2 drugs)
  • Your cancer got worse or came back less than 6 months after having pegylated liposomal doxorubicin or any other anthracycline Open a glossary item chemotherapy
  • You have had a new experimental treatment in the last 30 days 
  • You have moderate or severe numbness in your hands and feet (neuropathy) 
  • You have had severe side effects from pegylated liposomal doxorubicin
  • You have or have had heart problems such as angina that is not controlled, heart attack, irregular heartbeat, problems in the membranes that surround the heart (the pericardium) or any other serious condition in the last 6 months
  • You have had problems in your liver 
  • You have an infection Open a glossary item that needs treatment
  • You need to have the yellow fever vaccine during the trial
  • You are sensitive to trabectedin, the yellow fever vaccine or anything it contains 
  • You have any other serious medical condition that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 588 people to take part worldwide and hope that around 50 people from the UK will take part. 

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • carboplatin and pegylated liposomal doxorubicin 
  • trabectedin and pegylated liposomal doxorubicin 

Neither you nor your doctor will be able to decide which group you are. 

Diagram for INOVATYON

Carboplatin and pegylated liposomal doxorubicin 
You have treatment every 4 weeks. You have pegylated liposomal doxorubicin as a drip into a vein. It takes about 60 minutes. 

Then you have carboplatin. You also have it as a drip into a vein. It takes between 30 to 60 minutes. 

You continue to have both drugs for as long as it is helping you and the side effects aren’t too bad. You can have up to 6 treatments.  

After 6 treatments you may be able to continue on the trial if it is still helping you. Your doctor can tell you more about this. 

Trabectedin and pegylated liposomal doxorubicin 
You have treatment every 3 weeks. First, you have a drug called dexamethasone. You have it as a drip into a vein. It takes about 30 minutes. 

Then you have pegylated liposomal doxorubicin and trabectedin. You have both drugs as a drip into a vein. It takes around 4 hours. 

You continue to have treatment for as long as it is helping you and the side effects aren’t too bad. You can have up to 6 treatments. 

You may also be able to continue on the trial after 6 treatments if it is still helping you. You doctor can tell you more about this.     

Quality of life 
Everybody taking part of this trial completes a quality of life questionnaire:

  • before starting treatment
  • after you finish your treatment

It asks about how you have been feeling and what side affects you have had.

Blood tests 
You have some extra blood tests as part of this trial. The researchers want to look for a substance called CA-125 Open a glossary item.

The trial team may also ask you to have extra blood tests. They call this the pharmacokinetic study.  

You have 9 extra blood tests:

  • before the start of treatment
  • at set times after the first treatment

Researchers want to find out what happens to trabectedin in your body. They need about 10 people to take part in this research. 

Abdominal (tummy) fluid test 
The trial team may also ask you to have samples of the abdominal fluid (ascites Open a glossary item) taken. 

You have 9 abdominal fluid samples:   

  • before the start of treatment
  • at set times after the first treatment

This is also part of the pharmacokinetic study. Researchers need around 10 people to take part in this research.

Hospital visits

You see a doctor and have some tests before taking part. These tests include: 

  • a physical examination
  • heart trace (ECG Open a glossary item
  • echocardiogram Open a glossary item or MUGA scan Open a glossary item 
  • a CT scan or MRI scan
  • blood tests
  • urine test

You see the trial doctor for blood tests and a physical examination every 3 or 4 weeks. 

You have a CT or an MRI scan every 3 months while you are having treatment. This continues for as long as your cancer stays the same and does not get worse. If your cancer gets worse you stop having treatment. 

When you finish your treatment you see the trial team:

  • every 3 months for the first 2 years 
  • then every 6 months

Side effects

The trial team monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

The most common side effects of trabectedin are:

We have more information on trabectedin.  

We also have information on:

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

Questions about cancer? Contact our information nurses

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.

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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