ASSG 03-10 AYAPK
ACTRN12609000956202
Treatment
Not Applicable
Government body,Victorian Cancer Agency
Dr Sally Whyte
Currently the doses of medication given to treat cancer are generally determined by a simple body surface area (BSA) calculation based on weight and height. However, physiological differences between individuals may affect the way cancer drugs are processed by the body, potentially leading to variable dose levels in the body, and differences in toxicity and efficacy between individuals. This study is looking at the way the body processes the drug doxorubicin (this is called pharmacokinetics and .... Read more
Newly diagnosed with osteosarcoma, Ewing family of tumours or Hodgkin lymphoma; aged between 1 year and 40 years of age; planned treatment involves a standard doxorubicin-containing regimen; written informed consent from patient and/or patient’s parent or legal guardian
Impaired hepatic function such as known chronic liver disease, evidence of impaired synthetic function or transaminases raised >5 x normal; significant uncontrolled systemic illness as judged by investigator; females who are pregnant or breast feeding
No
Sample Size 79
Min. age 1 Years
Max. age 40 Years
Sex Both males and females
Condition category Ewing Family of Tumours , Hodgkin Lymphoma , Osteosarcoma
Condition code Cancer
Intervention code Other interventions
Experimental drug treatments are not part of this study. Patients will receive chemotherapy that is standard of care at their hospital. Blood samples for pharmacokinetics will be collected immediately prior to cycle 1 doxorubicin administration and at 0.5, 1, 3, & 6 hours after the end of the infusion, then at 24, 48 and 72 hours. Pharmacodynamics will be assessed using body composition assessments before patients commence chemotherapy. Body composition will be assessed by height and weight; bio .... Read more
Control group Uncontrolled
None
Outcome: To evaluate the effect of gender on the pharmacokinetics of doxorubicin in Adolescent and Young Adult with newly diagnosed Hodgkin lymphoma, osteosarcoma and Ewing family of tumours by comparing doxorubicin concentration-time curve area under the curve (AUC) against gender.Timepoint: Cycle 1 of first infusion doxorubicin treatment
yes
De-identified IPD data collected throughout the study
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis. Assessed on a case-by-case basis.