This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Doxorubicin Pharmacokinetic (PK) Study

This study has been terminated.
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by:
Boston Children’s Hospital Identifier:
First received: July 7, 2005
Last updated: January 17, 2006
Last verified: January 2006
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.

Condition Intervention Phase
Cancer Drug: Doxorubicin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

Resource links provided by NLM:

Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 9
Study Start Date: June 2003

Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00124956

United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Principal Investigator: Holcombe Grier, MD Dana Farber Cancer Insitute
  More Information Identifier: NCT00124956     History of Changes
Other Study ID Numbers: 03-04-050
Study First Received: July 7, 2005
Last Updated: January 17, 2006

Additional relevant MeSH terms:
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017