A trial looking at chemotherapy for advanced solid tumours (PH1/094)

Cancer type:

All cancer types




Phase 1

This trial was looking at a combination of decitabine and epirubicin for advanced solid tumours (not leukaemia or lymphoma). This trial was supported by Cancer Research UK.

Epirubicin is a chemotherapy drug that is already used to treat some cancers. Doctors hoped that giving decitabine at the same time would make epirubicin more effective.

The aims of this trial were to find out

  • The best dose of decitabine to give alongside epirubicin
  • More about the side effects

Summary of results

This trial showed that, even at a low dose, decitabine given alongside epirubicin can cause serious side effects.

This was a phase 1 trial. Everyone taking part had both decitabine and epirubicin. Some people had decitabine over 5 days, and some had it in one dose. Everyone had one dose of epirubicin on day 10 of each 3 week cycle of treatment.

The trial was designed as a dose escalation study. This means that the first few people taking part have the lowest dose. And the next few people have a higher dose. And so on until the trial team find the best does to give. But the people having the lowest dose of decitabine had quite severe side effects. So the research team didn’t give anyone a higher dose.

The trial recruited 14 patients. One was unable to have treatment and 11 left the trial early. Some left because their cancer continued to grow and they were too unwell for treatment. Some left because they had serious side effects. Two people had the planned 6 cycles of treatment or more.

The most common side effect was a drop in white blood cells and red blood cells causing an increased risk of infection and tiredness.

Other side effects included

The trial team concluded that they were unable to find the best dose of decitabine to give alongside epirubicin, because the people having the lowest dose had side effects.

Although it was difficult to draw conclusions because of the small number of people having treatment, they didn’t find any evidence that this new combination worked well as a treatment for cancer.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. The figures we quote above were provided by the trial 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

Professor J Cassidy
Professor C Twelves
Dr D Jodrell

Supported by

Cancer Research UK (Centre for Drug Development)

Other information

This is Cancer Research UK trial number CRUKD/04/038.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 303

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

Last reviewed:

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