Doxorubicin Pharmacokinetic (PK) Study

Overview[ - collapse ][ - ]

Purpose 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.
ConditionCancer
InterventionDrug: Doxorubicin
PhasePhase 1/Phase 2
SponsorChildren's Hospital Boston
Responsible PartyChildren's Hospital Boston
ClinicalTrials.gov IdentifierNCT00124956
First ReceivedJuly 7, 2005
Last UpdatedJanuary 17, 2006
Last verifiedJanuary 2006

Tracking Information[ + expand ][ + ]

First Received DateJuly 7, 2005
Last Updated DateJanuary 17, 2006
Start DateJune 2003
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresTo evaluate the relationship between obesity and doxorubicin pharmacokinetics in children
Current Secondary Outcome MeasuresTo 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)

Descriptive Information[ + expand ][ + ]

Brief TitleDoxorubicin Pharmacokinetic (PK) Study
Official TitleImpact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1/Phase 2
Study DesignAllocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionCancer
InterventionDrug: Doxorubicin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment9
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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
GenderBoth
Ages1 Year
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00124956
Other Study ID Numbers03-04-050
Has Data Monitoring CommitteeNot Provided
Information Provided ByChildren's Hospital Boston
Study SponsorChildren's Hospital Boston
CollaboratorsGlaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Investigators Principal Investigator: Holcombe Grier, MD Dana Farber Cancer Insitute
Verification DateJanuary 2006

Locations[ + expand ][ + ]

Children's Hospital, Boston
Boston, Massachusetts, United States, 02115