A study looking at cediranib with or without gefitinib for a type of brain tumour called a glioblastoma (DORIC)

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

Cancer type:

Brain (and spinal cord) tumours




Phase 2

This study is comparing a combination of cediranib and gefitinib with cediranib alone in people who have glioblastoma that has come back after treatment. This trial is supported by Cancer Research UK.

Glioblastoma multiforme is one of the most common types of brain tumour in adults. Standard treatment Open a glossary item for glioblastoma is surgery, followed by radiotherapy and a chemotherapy drug called temozolomide.

Unfortunately, glioblastoma often starts to grow again after treatment. When this happens it is very difficult to control and doctors are always trying to find new ways of treating it. In this trial, doctors are looking at 2 drugs called cediranib and gefitinib.

Cediranib is a type of biological therapy called an anti angiogenic drug. These stop the cancer growing new blood vessels. All cells need a blood supply to grow, so the researchers hope that cediranib will slow or stop the cancer growing.

Gefitinib is a type of drug called a tyrosine kinase inhibitor (TKI). It works by blocking receptors on cancer cells that trigger the growth of the cells. Doctors hope that by blocking these receptors, they will be able to stop or slow down the growth of cancer cells.

The aim of this trial is to find out if the combination of cediranib and gefitinib works better than cediranib alone for glioblastoma that has come back after treatment.

Who can enter

You can enter this trial if you

  • Have a glioblastoma that has come back after standard treatment Open a glossary item
  • Have cancer that has been measured on a MRI scan in the last week, is at least 10mm in size, and you did not take steroids for 5 days before the scan (unless it was a stable dose that did not change during those 5 days)
  • Have not had temozolomide for at least 4 weeks
  • Are able to care for yourself but not able to carry on with all your normal activities or do active work (Karnofsky performance status of 70 or above)
  • Have satisfactory blood and urine test results
  • Have satisfactory neurological tests
  • Are willing to use reliable contraception while you are on the study and for 2 weeks after you have finished treatment if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have had treatment for your brain tumour other than surgery, radiotherapy or temozolomide
  • Have had radiosurgery or brachytherapy Open a glossary item
  • Have had major surgery or a brain biopsy Open a glossary item in the last 14 days
  • Have had a craniotomy in the last 4 weeks
  • Are having any other treatment for your brain tumour except steroids.
  • Have had radiotherapy to the head in the last 3 months
  • Have had any previous biological therapy
  • Have had any recent significant bleeding in to your brain
  • Are unable to swallow or absorb tablets
  • Have a wound that has not healed
  • Have or have had high blood pressure that cannot be lowered with tablets
  • Have a heart problem that is cause for concern or any other serious medical problems (the trial doctor can advise you about this)
  • Have had severe bleeding in the last 3 months, or have coughed up more than a teaspoonful of blood in the last 4 weeks
  • Have had any other cancer, apart from carcinoma in situ or non melanoma skin cancer that was successfully treated at least 5 years ago
  • Have taken a high dose of steroids in the last 2 weeks, your doctor will discuss this with you
  • Are hepatitis B, hepatitis C or HIV positive
  • Are taking a certain type of anti fit ( anti-epileptic) medication, your doctor will discuss this with you
  • Have not fully recovered from your previous brain tumour treatment
  • Have taken part in this study in the past
  • Have had an experimental drug as part of another clinical trial in the last 30 days
  • Are pregnant or breastfeeding

Trial design

This trial will recruit 112 people from the UK. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in either. This is called a double blind trial.

  • People in group 1 have cediranib and gefitinib
  • People in group 2 have cediranib and a dummy drug (placebo Open a glossary item)

Cediranib, gefitinib and the dummy drug are tablets that you take daily. You can continue to take the tablets for as long as they help you.

You fill out a questionnaire before you start treatment, 6 weeks later, and then every 3 months until you stop treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask you for a tissue sample taken when you had surgery to remove your cancer. The researchers would also like some extra blood samples from you. These samples will help them to learn more about how cediranib works in the body. If you don’t want to give tissue or blood samples for research, you don’t have to. You can still take part in the main trial.

The trial doctors will ask you to consider giving them permission to take a biopsy of your cancer after you have died. You may wish to discuss this with your family. If you do not want to give your permission then you can still take part in the trial.

Hospital visits

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

  • Physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Tests on your nervous system (neurological examination)
  • Being asked a number of questions to look at your memory and attention (mental ability tests)
  • A urine test
  • MRI scan of the brain

For the first 6 weeks you will visit the doctors each week for a physical examination and blood test. At week 3 you will also have a heart trace (ECG) and neurological examination. At week 6 you will have a mental ability test.

After the first 6 weeks you will come into the hospital every 3 weeks for a check up. You will have the following tests every 6 weeks during the rest of your treatment and when you stop the treatment

  • Physical examination
  • Neurological examination
  • Blood test and urine tests
  • MRI scan
  • Heart Trace (ECG), only when you stop treatment

After you finish treatment, a member of the research team will contact you by phone every 3 months to see how you are.

Side effects

The most common side effects of gefitinib are

The most common side effects of cediranib are

There is more information about gefitinib on CancerHelp UK.

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 Paul Mulholland

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Institute (NCRI)
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUKE/10/044.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6197

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

Rhys was only four years old when he was diagnosed with a brain tumour

A picture of Rhys

"He went through six operations and was placed on a clinical trial so he could try new treatments.”

Last reviewed:

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