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

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

• Hair loss
• Constipation
• Feeling or being sick

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 ) 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.