Data

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.
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Subjects

Chemotherapy |

Source Study

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 ....
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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    210

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 ....
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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

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au