A trial to find out how well gemcitabine and oxaliplatin work for children and young people with cancer (CCLG NAG 2007 01)

Cancer type:

Children's cancers

Status:

Results

Phase:

Phase 2

This trial looked at the chemotherapy drugs gemcitabine and oxaliplatin, to find out how well they worked for children with solid tumours Open a glossary item , and to understand more about their side effects. The trial recruited children and young people whose solid tumour had continued to grow or came back despite treatment.

This trial was for children and young people up to and including the age of 20. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

Gemcitabine is used to treat many different types of cancer affecting adults. We know from research that it might be a useful treatment for children.

Oxaliplatin is also used to treat adults with cancer, and was being looked at as a possible treatment for children. Doctors thought that gemcitabine and oxaliplatin may work better if your child had them together.

The aims of this trial were to find out how well this combination of drugs worked and what the side effects were.

Summary of results

The trial team found that the combination of gemcitabine and oxaliplatin was safe to give. But the combination didn’t work as well as they had hoped.

This trial recruited 93 children.

After 4 cycles of treatment the trial team looked at how well the children had responded to treatment. They found that of the 93 children, in

4 children their tumour had shrunk – partial response
26 children their tumour had stayed the same – stable disease
63 children their tumour had continued to grow

The most common side effects were

The trial team concluded that although the combination of gemcitabine and oxaliplatin was safe it did not work very well for children whose solid tumour had come back or continued to grow despite treatment.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.