A trial of AZD1775 for head and neck cancer (WISTERIA)

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Coronavirus and cancer

We know it’s a worrying time for people with cancer, we have information to help. If you have symptoms of cancer contact your doctor.

Read our information about coronavirus and cancer

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

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at using a new drug called AZD1775 before surgery and after surgery for head and neck cancer. It is for people who have one of the following head and neck cancers:

  • mouth (oral) cancer
  • cancer of the voice box (larynx)
  • cancer where the food pipe surrounds the voice box (hypopharynx)

study diagram

More about this trial

The standard treatment for head and neck cancer is surgery. After surgery you might have a chemotherapy drug called cisplatin with, or without, radiotherapy

Laboratory studies show that AZD1775 helps cisplatin and radiotherapy to work better.

In this trial, researchers want to find out if AZD1775 can be used with surgery, chemotherapy and, or, radiotherapy for people with a head and neck cancer. 

There are 2 groups in this trial. 

  • The 1st group have AZD1775 and cisplatin before surgery. 
  • The 2nd group have radiotherapy, cisplatin and AZD1775 after surgery. 

The aims of this trial are to find:

  • the best dose of AZD1775 to have with cisplatin before surgery
  • the best dose of AZD1775 to have with radiotherapy and cisplatin after surgery
  • what happens to AZD1775 in the body
  • how having AZD1775 with cisplatin and radiotherapy after surgery affects people’s quality of life

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. 

Who can enter

You may be able to join this trial if all of the following apply. 

You have one of the following cancers that is a squamous cell cancer.

And all of the following must apply. You:

  • are to have surgery with the aim to cure your cancer 
  • are able to carry out all your daily activities apart from heavy physical work (performance status 0 or 1)
  • have satisfactory blood test results
  • are willing to use reliable contraception starting 2 weeks before treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
  • are between 18 and 70 years old

People in group A must also be able to have a small piece of tissue (biopsy) taken from their cancer.

People in group B must also be at high risk of their cancer coming back after surgery, for example the cancer has spread to lymph nodes. 

People who had treatment as part of Group A before their surgery might also be considered for Group B. 

Who cannot enter

You can’t join this trial if any of these apply. 

Cancer related
You have:

  • cancer in the part of the throat just behind the mouth (oropharynx)
  • already had treatment for a head and neck cancer apart from laser therapy for carcinoma in situ that hasn’t affected you very much, for example how you swallow or speak
  • cancer that has spread to another part of the body 

Medical conditions
You:

  • have heart problems such as a heart attack in the past 6 months, heart failure or unstable angina
  • have a problem with your digestive system, such as Crohn’s disease, coeliac disease or ulcerative colitis, that can affect how you absorb tablets
  • are unable to swallow tablets
  • have nerve damage that interferes with your daily activities
  • are not able to have cisplatin
  • are taking drugs that affect how AZD1775 is absorbed in the body 
  • have taken an experimental drug as part of another clinical trial within 4 weeks of joining this trial
  • are taking part in another clinical trial
  • have any other medical or mental health problem that your doctor think might affect you taking part in this trial

Other
You are:

  • allergic to the drugs, or their ingredients, used in this trial
  • pregnant or breastfeeding

Trial design

This is a phase 1 trial. There are 2 groups in this trial. The trial team need up to 42 people in total to join. 

  • 21 people in group A
  • 21 people in group B

As part of the trial researchers want to find the best dose of AZD1775 to give. The first 3 people in each group have a low dose of AZD1775. If they don’t have any bad side effects the next 3 people have a higher dose. And so on until the highest safe dose is found. 

Group A
You have treatment for up to 2 weeks as long as the side effects aren’t too bad. 

The first week you:

  • take AZD1775 twice a day for 3 days
  • have a sample of your cancer (biopsy) taken on day 3
  • no treatment for 4 days

The second week, you 

  • take AZD1775 twice a day for 3 days
  • have a drip of cisplatin on the first day of the second week 
  • then surgery to remove your cancer within 6 weeks of starting your treatment and if possible another sample of cancer tissue is taken 


Group B

Within 3 months of having surgery you:

  • have radiotherapy Monday to Friday for 6 weeks
  • have a drip of cisplatin on the Tuesday each week for 5 weeks
  • take AZD1775 twice a day for 3 days during weeks 1, 2, 4 and 5 (Tuesday, Wednesday and Thursday)

WISTERIA diagram - Group BYou have an appointment to plan your radiotherapy before starting treatment. This is so the radiotherapy team can work out the correct dose of radiotherapy to give.

You have a planning CT scan that shows where the cancer is and the surrounding structures. This can take up to a couple of hours. 

You have a mask (mould) of your head made. You have an appointment with the mould technician or radiographer to have this done. It can take up to an hour. The mask is used during the radiotherapy treatment to keep your head still.

AZD1775 are tablets you take twice a day. You take it on an empty stomach. This means taking it about 2 hours before food or 2 hours after food. You have a diary to record when you take the tablets. 

You have cisplatin as a drip into a vein.

Blood and tissue samples
You have regular blood samples taken during and after treatment. Researchers will use these samples to find out what happens to AZD1775 and cisplatin in the body. They want to know how it is:

  • absorbed
  • broken down (metabolised)
  • removed 

The trial team will ask for a sample of tissue (biopsy) from when you had your cancer diagnosed. 

Quality of life
People in group B fill in a questionnaire:

  • when you start treatment 
  • at the end of treatment
  • 3 months after the end of treatment
  • 6 months after the end of treatment
  • 12 months after the end of treatment 

The questions ask about: 

  • your general health
  • how you are feeling
  • any side effects you might have

This is called a quality of life questionnaire.

Hospital visits

Everyone sees the doctor to have some tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • heart scan (ECHO or MUGA)
  • CT scan (group A only)
  • hearing test
  • heart trace (ECG)

Group A
You see the doctor when you start treatment (day 1) to see how you are and have:

  • a physical examination
  • blood tests
  • heart trace (ECG)

During treatment you see the doctor before you have cisplatin (day 8) for the same.

At the end of treatment you see the doctor for:

  • blood tests
  • heart trace

After treatment you see the doctor 1 month and 3 months to see how you are and for blood tests. 

Group B
During treatment you see the doctor every week to see how you are and for:

  • a physical examination
  • blood tests
  • heart trace

At the end of treatment you see the doctor for:

  • blood tests
  • heart trace

After treatment you see the doctor: 

  • every week for 6 weeks
  • 3 months
  • 6 months
  • 1 year

This is to see how you are and for blood tests.

Side effects

AZD1775 is a new drug and there may be side effects we don’t know about yet. Your doctors and nurses will monitor you closely when you’re taking AZD1775.

The most likely side effects include:

We have information about:

Your doctor will talk to you about all the possible side effects before you agree to take part in the trial.

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

Professor Hisham Mehanna

Supported by

AstraZeneca
Cancer Research UK
University of Birmingham 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14313

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

A picture of Wendy

"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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