Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00673257
Registration number
NCT00673257
Ethics application status
Date submitted
6/05/2008
Date registered
7/05/2008
Date last updated
14/04/2020
Titles & IDs
Public title
Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Query!
Scientific title
Pharmacokinetics of Daunomycin in Children
Query!
Secondary ID [1]
0
0
CDR0000490024
Query!
Secondary ID [2]
0
0
ABTR06C1
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Unspecified Childhood Solid Tumor, Protocol Specific
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - pharmacological study
Treatment: Surgery - dual x-ray absorptimetry
Experimental: Pharmacokinetics of Daunorubicin chemotherapy patients - Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
Other interventions: pharmacological study
pharmacological studies
Treatment: Surgery: dual x-ray absorptimetry
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Population Estimates for Daunorubicin Hydrochloride Clearance
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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.
Query!
Primary outcome [2]
0
0
Population Estimates for Daunorubicin Hydrochloride Volume of Distribution
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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.
Query!
Secondary outcome [1]
0
0
Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride
Query!
Assessment method [1]
0
0
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by Body composition (<30% versus >=30%)
Query!
Timepoint [1]
0
0
Length of study
Query!
Secondary outcome [2]
0
0
Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background
Query!
Assessment method [2]
0
0
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)
Query!
Timepoint [2]
0
0
Length of Study
Query!
Secondary outcome [3]
0
0
Relationship Between Pharmacokinetics and Toxicity
Query!
Assessment method [3]
0
0
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized for occurrence of various toxicities
Query!
Timepoint [3]
0
0
Length of Study
Query!
Secondary outcome [4]
0
0
Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count
Query!
Assessment method [4]
0
0
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by organ function/baseline laboratory values
Query!
Timepoint [4]
0
0
Length of Study
Query!
Secondary outcome [5]
0
0
Relationship Between Pharmacokinetics, and Genetic Polymorphisms
Query!
Assessment method [5]
0
0
Mean (standard deviation) of daunorubicin hydrochloride clearance will be summarized by genotype
Query!
Timepoint [5]
0
0
Length of Study
Query!
Eligibility
Key inclusion criteria
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
Query!
Minimum age
No limit
Query!
Query!
Maximum age
21
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Basic Science
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/03/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
107
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
Princess Margaret Hospital for Children - Perth
Query!
Recruitment postcode(s) [1]
0
0
6001 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Delaware
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Mississippi
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Mexico
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Washington
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Wisconsin
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Quebec
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Saskatchewan
Query!
Country [32]
0
0
Switzerland
Query!
State/province [32]
0
0
Bern
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Children's Oncology Group
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Government body
Query!
Name [1]
0
0
National Cancer Institute (NCI)
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00673257
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Stacey L. Berg, MD
Query!
Address
0
0
Texas Children's Cancer Center
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00673257
Download to PDF