Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Pharmacokinetics of Daunomycin in Children
Secondary ID [1] 0 0
CDR0000490024
Secondary ID [2] 0 0
ABTR06C1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - pharmacological study

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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Population Estimates for Daunorubicin Hydrochloride Clearance
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.
Primary outcome [2] 0 0
Population Estimates for Daunorubicin Hydrochloride Volume of Distribution
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.
Secondary outcome [1] 0 0
Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride
Timepoint [1] 0 0
Length of study
Secondary outcome [2] 0 0
Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background
Timepoint [2] 0 0
Length of Study
Secondary outcome [3] 0 0
Relationship Between Pharmacokinetics and Toxicity
Timepoint [3] 0 0
Length of Study
Secondary outcome [4] 0 0
Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count
Timepoint [4] 0 0
Length of Study
Secondary outcome [5] 0 0
Relationship Between Pharmacokinetics, and Genetic Polymorphisms
Timepoint [5] 0 0
Length of Study

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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
Country [32] 0 0
Switzerland
State/province [32] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00673257
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stacey L. Berg, MD
Address 0 0
Texas Children's Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00673257