A trial looking at crizotinib for advanced cancer (CREATE)

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

Cancer type:

Blood cancers

High grade lymphoma

Kidney cancer

Lymphoma

Non-Hodgkin lymphoma

Renal cell cancer

Sarcoma

Soft tissue sarcoma

Status:

Closed

Phase:

Phase 2

This trial is looking at crizotinib (Xalkori) for people who have advanced cancer and changes to genes called ALK or MET.

This trial is for children as well as adults. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

More about this trial

Crizotinib is a type of biological therapy. It is a cancer growth blocker called a tyrosine kinase inhibitor (TKI). It stops the signals cells use to divide and grow.

Genes are coded messages that tell cells how to behave. Sometimes genes have changes (mutations Open a glossary item ) in the code and this can affect how cells behave and respond to treatment. Researchers think that crizotinib may work better on cancer cells that have a change in genes called ALK or MET.

This trial is recruiting people with a number of rare cancers that have been shown to have changes in ALK or MET in some patients. These are detailed in the ‘who can enter’ section of this summary.

The aims of the trial are to find out

How well crizotinib works for certain types of cancer
Whether ALK or MET gene changes affect how well crizotinib works
More about the side effects

Who can enter

You may be able to enter this trial if you have already had treatment for one of the following cancers

A type of high grade non Hodgkin lymphoma called anaplastic large cell lymphoma (ALCL)
A rare soft tissue cancer called inflammatory myofibroblastic tumour (IMFT)
A rare form of soft tissue sarcoma called alveolar rhabdomyosarcoma (ARMS)

This study was also recruiting people who’d had treatment for the following cancers, but these groups aren’t recruiting patients at the moment

A rare form of soft tissue sarcoma called alveolar soft part sarcoma (ASPS)
A rare form of soft tissue sarcoma called clear cell sarcoma (CCSA)
A rare form of kidney cancer called papillary renal cell cancer type 1 (PRCC)

As well as having one of these cancers, you must

Have an area of cancer that can be measured on a scan
Have satisfactory blood test results
Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Be willing to use reliable contraception during the trial and for 3 months afterwards, if there is any chance that you or your partner could become pregnant
Be at least 1 year old

You cannot enter this trial if you

Have cancer that has spread to the brain, unless it has been successfully treated and you don’t need to take steroids
Have had treatment in the last 4 weeks, apart from radiotherapy which was for symptom control only
Have taken part in another clinical trial in the last 4 weeks
Have had crizotinib or any other treatment which targets ALK or MET before
Have had any other cancer, apart from non melanoma skin cancer or a very early stage cancer that has been successfully treated
Are still having side effects from earlier treatment
Have a long term condition affecting your stomach or bowel, such as an ulcer or diarrhoea
Have certain heart problems (the trial team can advise you about this)
Have a condition called severe interstitial lung disease
Are taking medication or herbal supplements that can affect CYP3A enzymes, including some antibiotics, some anti epileptic drugs and St John’s Wort
Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The trial team are hoping to recruit up to 420 patients from several countries. Everyone taking part will have one of the cancers listed above, and will have had all available treatments.

You take crizotinib capsules twice a day, every day. You can take it for as long as it is working, unless you have serious side effects.

The research team will need to look at a sample of your cancer so they can check if you have a change to the ALK or MET gene. They will also ask for a sample of your cancer to help with their future research. If you don’t want to give this extra sample for research, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctor and have some tests before you take part in the trial. The tests include

Physical examination
Blood tests
Eye examination and test
Heart trace (ECG )
CT scan or MRI scan

When the research team check for changes to the ALK or MET genes, they may be able to use a sample that was taken when you had a biopsy Open a glossary item or surgery. If not, you will need to have a biopsy before you can join the trial.

While you are having treatment you will have

Physical examination every 3 weeks
Blood tests after 2 and 3 weeks of treatment, and then every 3 weeks after that
Urine test after 6 weeks
CT or MRI scan every 6 weeks
Heart trace (ECG) after 3, 6 and 9 weeks and then every 12 weeks after that
Eye test every 12 weeks

After you finish treatment you will see the doctors and have a physical examination, blood tests and a scan. They will keep an eye on you for a month after you stop treatment to make sure you don’t have any serious side effects. After that you will continue to see your own doctor. The research team will ask your doctor how you are doing every 3 months.

Side effects

The most common side effects of crizotinib are

Feeling or being sick
Diarrhoea or constipation
Changes to your eyesight such as blurred vision, double vision or flashing lights
Fluid build up which can cause swelling of your arms, legs or face
Taste changes or loss of appetite
Dizziness
Tiredness (fatigue)

Some other medicines may increase the harmful effects of this drug. You should also avoid grapefruit and grapefruit juice because they can increase the side effects.

We have more information about crizotinib.

Recruitment start:

01/07/2013

Recruitment end:

04/07/2017

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Dr Sandra Strauss

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Pfizer

Freephone 0808 800 4040

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