N/A
N=107
Pharmacokinetics of Daunorubicin in Young Patients With Cancer
Unspecified Childhood Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00673257 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Population Estimates for Daunorubicin Hydrochloride Clearance — 116 L/m2/hr
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pharmacological study (Other); dual x-ray absorptimetry (Procedure)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population Estimates for Daunorubicin Hydrochloride Clearance |
116 | — |
| PRIMARY Population Estimates for Daunorubicin Hydrochloride Volume of Distribution |
68.1 | — |
| SECONDARY Relationship Between Body Composition and the Pharmacokinetics of Daunorubicin Hydrochloride |
— | — |
| SECONDARY Correlation of the Pharmacokinetics of Daunorubicin Hydrochloride With Gender, Age, or Ethnic Background |
— | — |
| SECONDARY Relationship Between Pharmacokinetics and Toxicity |
— | — |
| SECONDARY Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count |
— | — |
| SECONDARY Relationship Between Pharmacokinetics, and Genetic Polymorphisms |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00673257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.