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

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

Cancer type:

Oesophageal cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at a drug called AZD8931 alongside chemotherapy for cancer of the food pipe (oesophageal cancer) or cancer where the oesophagus meets the stomach (the gastro-oesophageal junction). The trial is supported by Cancer Research UK.

Doctors can treat cancer of the oesophagus or gastro-oesophageal junction with chemotherapy. Capecitabine and oxaliplatin are 2 drugs they may use. This combination of drugs is called XELOX. In this trial, researchers are looking at adding a drug called AZD8931 to XELOX chemotherapy.

AZD8931 is a type of biological therapy. 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 are to

  • Find the highest dose of AZD8931 that you can have safely with XELOX chemotherapy
  • See if AZD8931 and chemotherapy works better than chemotherapy alone for cancer of the oesophagus or gastro-oesophageal junction

Who can enter

The trial is in 2 parts. You may be able to enter the 1st part of the trial if you have adenocarcinoma of the oesophagus or gastro-oesophageal junction that has grown into local tissue (locally advanced) or has spread to other parts of your body.

You may be able to enter the 2nd part of the study if you have cancer of the oesophagus or gastro-oesophageal junction that your doctors think can be removed with surgery after chemotherapy.

As well as the above, for both parts of the trial you must

  • Be well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Be able to swallow tablets
  • Be at least 18 years old
  • Be willing to use a reliable form of contraception during the trial and for 6 months afterwards (for men) or 4 months afterwards (for women) if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have stomach (gastric) cancer or a cancer that started just below the gastro-oesophageal junction
  • Have a type of oesophageal cancer called squamous cell carcinoma
  • Have already had chemotherapy for adenocarcinoma of the oesophagus or gastro-oesophageal junction
  • Have had another experimental drug in the last 4 weeks
  • Have damage to the nerves in your hands or feet (peripheral neuropathy) unless it is very mild
  • Have had a heart attack in the last 6 months or have certain other heart problems – the trial team can advise you about this
  • Have ever had a disease affecting the lungs called interstitial lung disease
  • Have low levels of an enzyme called dihydropyrimidine dehydrogenase
  • Need to take other medication that can affect body substances called cytochrome P (CYP) enzymes
  • Have had another type of cancer in the last 5 years apart from non melanoma skin cancer, carcinoma in situ of the cervix or other cancers that have been successfully treated
  • Are known to be HIV, hepatitis B or hepatitis C positive, or have another infection or condition that affects your immune system Open a glossary item or your bone marrow Open a glossary item
  • Have had certain eye problems – the trial team can advise you about this
  • Are known to be very sensitive to any of the chemotherapy drugs being used in the trial
  • Have any other condition that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

As well as the above, you cannot enter the 2nd part of the trial if you have cancer that is at a very early stage (stage 1A) or are a woman who could possibly become pregnant.

Trial design

There are 2 parts to this phase 1 trial.

In the 1st part of the trial, the researchers are trying to find the highest dose of AZD8931 that you can have safely with chemotherapy. Up to 42 people will join this part of the trial. The first few patients taking part will have a low dose of AZD8931 alongside chemotherapy. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

To begin with, you take AZD8931 tablets on their own for 3 days. Then on the 4th day, you start XELOX chemotherapy in 3 week cycles of treatment.

You have oxaliplatin through a drip into a vein once every 3 weeks and take capecitabine tablets every day. You have up to 8 cycles of XELOX.

There are 2 different ways you can take AZD8931 tablets alongside XELOX. You either take them twice a day for the first 2 weeks of each 3 week treatment cycle. Or you take them twice a day on 4 days every week. Your doctor will advise you which way to take the AZD8931 tablets.

When you finish chemotherapy, you can carry on taking AZD8931on its own if the trial doctor thinks it is helping you.

The 2nd part of the trial is randomised. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • 20 people will have XELOX chemotherapy and AZD8931
  • 10 people will have XELOX chemotherapy alone

In this part of the trial, you have 2 cycles of XELOX chemotherapy with or without AZD8931. This takes 6 weeks. The people taking AZD8931 will all have the highest safe dose that was found in the 1st part of the trial.

Between 4 and 6 weeks after finishing chemotherapy, you have surgery to remove part of your food pipe and the upper part of your stomach (an oesophagogastrectomy).

If you are in the group having AZD8931 with chemotherapy and you have your cancer successfully removed, you can then start taking AZD8931 on its own. You start taking it again between 6 and 12 weeks after surgery. As long as you don’t have any bad side effects, and there is no sign of your cancer coming back, you can carry on taking AZD8931 for up to a year.

Hospital visits

You will see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Heart ultrasound (echocardiogram Open a glossary item)
  • CT scan

People joining the 2nd part of the study also have

If you are in the 1st part of the trial, you go to hospital once every 3 weeks while having chemotherapy. Each visit takes about 4 hours. If you carry on having AZD8931 on its own after finishing chemotherapy, you go to hospital once every 6 weeks until you stop treatment. These visits take about 2 hours each time.

At each hospital visit you have a physical examination, blood tests and an ECG. You have 2 more echocardiograms and 3 more CT scans during your chemotherapy.

If you carry on taking AZD8931 on its own, you have blood tests and an ECG every 6 weeks. You have a CT scan and a heart ultrasound every 12 weeks.

When you finish treatment, you go back to see the trial team a month later. At this visit, you have a physical examination and a heart ultrasound.

If you stop taking AZD8931 for any reason other than your cancer getting worse, the trial team will ask you to have a CT scan every 12 weeks until they can see that your cancer has grown.

If you are in the 2nd part of the trial, you go to hospital twice in 6 weeks to have chemotherapy. You have blood tests and an ECG at each visit. You have a CT scan and a PET scan at the end of your chemotherapy.

Between 4 and 6 weeks after you finish chemotherapy, you go into hospital to have surgery. You go back to see the trial team 4 to 6 weeks later.

If you carry on having AZD8931 on its own after surgery, you go to hospital once every 6 weeks. You have another CT scan 6 months after your operation and a heart ultrasound every 12 weeks.

When you finish treatment, you go back to see the trial team a month later. At this visit, you have a physical examination and a heart ultrasound.

Side effects

As AZD8931 is a new drug, there may be some side effects we don’t know about yet. The known side effects include

  • A skin rash particularly on your face, neck, chest, back and arms
  • Diarrhoea
  • Sore mouth
  • Sore eyes

AZD8931 may affect your heart. The trial team will monitor you closely during treatment and if they have any concerns, you will see a heart specialist (a cardiologist).

The side effects of XELOX chemotherapy include

Capecitabine can also cause changes to your heart.

Some people have an allergic reaction to oxaliplatin. You take steroid tablets Open a glossary item beforehand to try to stop this happening. Oxaliplatin can also affect the area around your voice box, causing swallowing problems and breathing difficulties. This can be made worse by cold temperatures, so you should not have cold drinks or ice cubes for a few days after each treatment.

We have more information about capecitabine and oxaliplatin in our cancer drugs section.

We have more information about having your operation in our oesophageal cancer section.

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:

Oracle 8934

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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