Doxorubicin Pharmacokinetic (PK) Study

Cancer Clinical Trial

Official title:

Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00124956
• Other study ID #: 03-04-050
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: July 7, 2005
• Last updated: September 7, 2017
• Start date: June 2003

Study information

• Verified date: September 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Doxorubicin

Locations

Country	Name	City	State
United States	Children's Hospital, Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Elizabeth Glaser Pediatric AIDS Foundation, Glaser Pediatric Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children
Secondary	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)