A trial looking at abiraterone for ovarian cancer that has come back (CORAL)

In this small trial the team found that abiraterone didn’t work as well as they had hoped. The trial closed earlier than planned.

Trial design
This trial was for people who had already had chemotherapy for ovarian cancer. And their cancer had continued to grow within a year of treatment. 

42 people joined the trial in total. They had all gone through the menopause . 

Everyone had abiraterone. They had treatment for as long as it was working and the side effects weren’t too bad. 

Results
The team checked how treatment was working. To do this they looked at scans and blood test results. 

They did this for the first 26 people who joined the trial. They then looked at the results of everyone who took part.

Results for the first 26 people in the trial
12 weeks after starting treatment the team found:

• the cancer had shrunk a little bit in 1 person
• the cancer had stayed the same in 6 people 

These results showed that treatment wasn’t working well enough. So the team looked in more detail at tissue samples  and blood samples. 

Some ovarian cancer cells have androgen receptors. Cancer cells that have a high number of this receptor are called androgen receptor positive cancer.  The receptors allow the cancer cells to use androgen to grow. The team wanted to see whose cancer was:

• androgen receptor positive (AR positive)
• androgen receptor negative (AR negative)

The aim was to see if this affected how well treatment worked. 
Of the first 26 people in the trial they found:

• 20 had cancer that was AR positive 
• 6 had cancer that was AR negative

A data monitoring committee  reviewed this data. This committee monitors the safety and design of trials. They used this information to decide if the trial should continue or not. They advised the trial team to close the trial early.  This was because abiraterone wasn’t working for enough people whose cancer was AR positive. 

Results for everyone who took part in the trial
While the team did the above analysis, the trial continued to recruit a few more people. The team also analysed the results for everyone who took part. This included 42 people. 

Here is a summary of what they found. 12 weeks after starting treatment the team looked at how well it had worked. They found:

• the cancer had shrunk a little bit in 1 person 
• the cancer had stayed the same in 10 people 

The team looked at how long before the cancer started to grow again. This was about 2.5 months. They also looked at how long people lived. This was about 11.8 months. 

Of the 42 people in the trial:

• 29 had cancer that was AR positive
• 11 had cancer that was AR negative
• the team didn’t know the AR status for 2 people 

Sub groups
The team also looked if there was a link between the following and how well treatment worked. They checked:

• if the cancer cells had high or low levels of androgen receptors 
• if the cancer had high or low levels of oestrogen receptors. This is oestrogen receptor positive or oestrogen receptor negative cancer. 
• the grade  of the cancer
• the number of chemotherapy treatments people had in the past 

They didn’t find a link with any of these and how well treatment worked. 

Side effects
Most of those who took part had side effects. Most of them were mild. The most common side effects of abiraterone were:

• tummmy (abdominal) pain 
• high blood pressure
• feeling sick
• constipation
• tiredness (fatigue)
• loss of appetite 

Some people had more severe side effects. These included high blood pressure and a drop in the amount of calcium in the blood. 

Conclusion
The trial team concluded that abiraterone did have an effect on ovarian cancer that had come back. It helped a few people who had slow growing epithelial ovarian cancer. But it didn’t work for enough people in this trial. So the trial closed earlier than planned. 
 
This was the first time people had abiraterone for ovarian cancer. The team think that it’s worthwhile investigating similar types of drugs in people with slow growing epithelial ovarian cancer. 

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 ) 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.