A trial of AZD8931 with chemotherapy for cancer of the oesophagus or the junction of the stomach and oesophagus (DEBIOC)

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Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 1

Oesophageal cancer is cancer of the food pipe and where the oesophagus meets the stomach is gastro-oesophageal junction cancer. 

Both these cancers are treated with the same chemotherapy. 

Cancer Research UK supported this trial.

More about this trial

Doctors treat cancer of the oesophagus and cancer of the gastro-oesophageal junction with combination of chemotherapy drugs called XELOX.
 
In this trial, researchers added AZD8931 to XELOX chemotherapy.
 
AZD8931 is a type of targeted cancer drug. It works by blocking certain proteins on the surface of cancer cells. These proteins play an important role in sending signals that tell cancer cells to divide. Turning off this signalling can help to kill cancer cells.
 
The aims of this trial were to:
  • find the best dose of AZD8931 to have with XELOX chemotherapy
  • see if AZD8931 and chemotherapy works better than chemotherapy alone for cancer of the oesophagus or gastro-oesophageal junction

Summary of results

The trial team found the best dose of AZD8931 to give with XELOX chemotherapy. But they found that the combination of AZD891 with XELOX was no better than XELOX only for oesophageal cancer and gastro oesophageal junction.
 
This trial was open for people to join between 2012 and 2016.
 
These results were presented at a conference in 2015 and 2018.
 
About this trial
There were 2 parts in this trial.
 
In part 1the first few people who joined had a low dose of AZD8931 with their XELOX chemotherapy. As they didn’t have any bad side effects the next few had a larger dose of AZD8931 with their XELOX chemotherapy.
 
And so on, until the researchers found the best dose of AZD8931 to give with XELOX chemotherapy.
 
In part 2 researchers wanted to find out more about the side effects of having AZD8931 with XELOX. And how well this combination might work for cancer of the oesophagus and gastro-oesophageal junction. This part included people who could have surgery after their treatment. 
 
Part 1 results
24 people joined this part. There were 4 groups. 
 
The team recorded the side effects for each person When a side effect was considered bad enough the dose of AZD8931 was either reduced or stayed the same for the next group. This is called a dose limiting toxicity. 
 
There were 4 side effects that resulted in a dose limiting toxicity:
  • fatigue
  • diarrhoea 
  • being sick
  • skin rash
20 of the 24 people (83%) had severe side effects, the most common being:
  • feeling and being sick
  • diarrhoea
  • infections
Part 2 results
30 people joined this part. 
 
This part was randomised Open a glossary item. Everyone was put into 1 of 2 treatment groups. Twice as many people had AZD8931 and XELOX. 
  • 20 people had AZD8931 and XELOX
  • 10 people had XELOX only

There was average follow up of just over 2 years (26.8 months).
 
The team then looked at the percentage of people whose cancer hadn’t got worse 6 months after randomisation. They found that it was:
  • 85 out of every 100 people (85%) for those who had AZD8931 and XELOX
  • 100 out of every 100 people (100%) for those who had XELOX only

People went on to have surgery 4 to 6 weeks after treatment.
 
After surgery to remove cancer doctors look at the border around the cancer they had removed to see if there are any cancer cells in it. This is called a clear margin Open a glossary item.
 
The researchers looked at the percentage of people who had a clear margin. They found this was:
  • 45 out of every 100 people (45%) who had AZD8931 and XELOX
  • 90 out of every 100 people (90%)who had XELOX only

The number of people who died due to their cancer was:
  • 7 people (35%) in the AZD8931 and XELOX group
  • 1 person (10%) in the XELOX only group
Side effects
The team looked at the percentage of people who had 1 or more severe side effects. They found it was:
  • 10 out of every 100 people (10%) in the AZD8931 and XELOX group
  • 50 out of every 100 people (50%) in the XELOX only group
Conclusion
The trial team concluded the best dose of AZD8931 to have with XELOX was 20mg twice a day for 4 days and then no treatment for 3 days each week.
 
They also concluded that the combination of AZD8931 and XELOX had acceptable side effects. But there was no suggestion that it was any better than XELOX only.
 
There are no plans to do further research.
 
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) 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.

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

Chief Investigator

Dr Anne Thomas

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Oxford

Other information

This is Cancer Research UK trial number CRUKD/12/007.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8934

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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