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Testing doxorubicin in paediatric oncology patients

The EPOC project is funded by the FP7 programme of the European Commission. It started in February 2009, and is projected to finish in 2013.

It may be considered a success that to date 63 of the proposed 100 patients have been recruited for the doxorubicin-study of the EU-funded project EPOC (European Pediatric Oncology Off-patent Medicine Consortium). EPOC intends to evaluate the age dependent toxicity of the widely used drug doxorubicin in pediatric oncology. Though it is used frequently in many different therapy protocols, the drug is still an off-label medicine, the way that the drug is handled in young children (its pharmacokinetics) have not yet been investigated in detail. Especially the anticipated different reactions in very young children (under three years of age) are not yet sufficiently known.

21 different peadiatric oncology departments in 4 different countries (Germany, France, Italy, UK) are involved in this study. Patients treated according to standard protocols which include doxorubicin as one of the protocol drugs are enrolled in this study. They get blood samples taken at different predefined time points which are sent for evaluation to the participating central lab in Münster (Germany). Drug concentrations, pharmacokinetics of doxorubicin and its metabolites are monitored.  Measurements are also made of blood markers that might indicate toxicity to the heart.

All patients enrolled and/or their parents have to give consent to this study (which is additional to the treatment protocol). As the testing also involves that a few samples have to be taken from peripheral veins or via a finger prick, some of the patients and/or their parents refuse to be enrolled as it means an extra burden on the patients, especially when the children are of younger age. Thus the recruitment in this specific age range is not as rapid as it was hoped to be – much to the frustration of the investigators.

On the other hand the researches could also state at their most recent meeting, that they are not too far away from their goal, considering the fact that it took much longer than anticipated to set up the structures for the entire study- basically due to very elaborate formal preparations asked for from the different national regulatory requirements and insurance regulations. It also took a little while for the involved clinicians to get used to the requirements of this study, to accept them as part of the routine. Thus, one is confident that the remaining patients will be enrolled within the timeframe of the project and the evaluation of all samples can be completed.

More information:

Gerlind Bode (patient representative)
Alan Boddy (project leader)

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