Doxorubicin Study

Eligibility Criteria

Patients receiving treatment with doxorubicin were eligible for enrolment provided that they were already registered on a European or national clinical study protocol.  Patients received doxorubicin according to that protocol.  Patients with the following tumour types were eligible for the trial:

  • Wilms Tumours
  • Neuroblastoma
  • Soft tissue sarcoma
  • Ewing Sarcoma
  • Acute Lymphoblastic Leukaemia

Exception:  Inclusion of patients <3 years was not limited to the above tumour types.

Paediatric patients up to the age of 17 years were included.

Sampling Schedule

The number and time points of PK sampling depended on the age of the patient and the tumour type.

PK samples were collected from two doxorubicin administrations to enable differences between  inter-individual, intra-individual and residual variability to be distinguished.

Number of Patients 

100 patients in the following age-groups:

  • Children 12-17 years (30 patients)
  • Children 3 to 11 years of age (50 patients)
  • Children < 3 year (20 patients)

A major focus of the recruitment was to target patients younger than 3 years, including at least 5 patients that were younger than 1 year. This was aimed at providing a good distribution of patient ages.