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Completed

NCT Number: NCT00673257

Pharmacokinetics of Daunorubicin in Young Patients With Cancer

This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.

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Key information

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

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About this study

OBJECTIVES:

Primary

  • Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.

Secondary

  • Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.
  • Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.
  • Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.
  • Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.
  • Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.

OUTLINE: This is a multicenter study.

Patients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacokinetic analysis.

Patients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of any malignancy
  • Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride administered as an infusion of any duration for < 24 hours on either a 1- or a 2-day schedule, including bolus and all short infusion schedules

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • No significant uncontrolled systemic illness
  • Large implanted prostheses allowed (should not undergo dual energy x-ray absorptiometry scan)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

pharmacological study

Other

pharmacological studies

dual x-ray absorptimetry

Procedure

Other names: DEXA scan, dual energy x-ray absorptimetry

Primary outcomes

  1. Population Estimates for Daunorubicin Hydrochloride Clearance

    Time frame: Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

    Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.

  2. Population Estimates for Daunorubicin Hydrochloride Volume of Distribution

    Time frame: Prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.

    Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.

Secondary outcomes

  1. Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride

    Time frame: Length of study

    Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%)

  2. Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background

    Time frame: Length of Study

    Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Gender (Male versus Female), Age group (<median age versus >=median age in years), Race (White vs. Black vs. Other)

  3. Relationship Between Pharmacokinetics and Toxicity

    Time frame: Length of Study

    Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities

  4. Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count

    Time frame: Length of Study

    Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values

  5. Relationship Between Pharmacokinetics, and Genetic Polymorphisms

    Time frame: Length of Study

    Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pharmacokinetics of Daunomycin in Children

Important dates

Study start
2007
Primary completion
2011
Study completion
2020
First posted
May 7, 2008
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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