Doxorubicin Pharmacokinetic (PK) Study

Phase 1

Withdrawn

• Conditions: Cancer

• Registration Number: NCT00124956
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-07-07
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-07-29
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Children's Hospital, Boston; 🇺🇸 Boston, Massachusetts, United States