Doxorubicin Pharmacokinetic (PK) Study

Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00124956

Enrollment

Registered

2005-07-29

Start date

2003-06-30

Completion date

Unknown

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

This protocol is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 9 children will be enrolled at Children's Hospital Boston. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population.

Interventions

DRUGDoxorubicin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 21 Years

Healthy volunteers

Inclusion criteria

* Eligible patients will be \> 1 and ≤ 21 years old. * All patients must be receiving chemotherapy that includes doxorubicin administered as an infusion of any duration \< 24 hours, on either a 1-day or 2-day schedule. This includes bolus and all short infusion schedules. * All patients or their parents/legal guardians will provide informed consent/assent (as required by law) indicating their awareness of the investigational nature and the risks of this study according to the informed consent process.

Exclusion criteria

* Women who are known to be pregnant or lactating * Patients with significant uncontrolled systemic illness * Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate transaminase (SGPT/ALT) \> 3 times the upper limit of normal tested within 14 days prior to infusion * Bilirubin \> the upper limit of normal tested within 14 days prior to infusion * Patients whose dose of doxorubicin is based on ideal body weight * Patients who weigh \< 12 kilograms at time of screening

Design outcomes

Primary

Measure	Time frame
To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children	—

Secondary

Measure	Time frame
To explore the relationship between PK parameters and the patients' characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026