AYAPK Pharmacokinetics and Pharmacodynamics of Doxorubicin in Children, Adolescents and young adults with Newly Diagnosed Osteosarcoma, Ewing Family of Tumours and Hodgkin Lymphoma A Multi-Institutional Cross-Discipline Non-Therapeutic Study
Australia and New Zealand Sarcoma Association(ANZSA)Dataset description
The dataset contains individual patient data for 66 participants. This includes data chemotherapy drug dosage, drug dose modification, site of disease and extent, disease progression, medical history and adverse events. Demographic data available: year of birth.Subjects
Chemotherapy |Identifiers
Source Study
Trial acronym
ASSG 03-10 AYAPK
Trial ID
ACTRN12609000956202
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,Victorian Cancer Agency
Scientific enquiries
Dr Sally Whyte
Brief Summary
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
Key Inclusion Criteria
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
Key Exclusion Criteria
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
Can healthy volunteers participate?
No
Population
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
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
Comparison
Control group Uncontrolled
None
Outcomes
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
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
De-identified IPD data collected throughout the study
When will data be available?
Data available 3 months following publication, for an indefinite period
Available to whom?
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.
Available for what types of analyses?
Any type of analysis. Assessed on a case-by-case basis.