Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00897871

First received: May 9, 2009

Last updated: December 6, 2011

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

December 6, 2011

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic parameters [ Designated as safety issue: No ]
Pharmacokinetic modelling comparing pharmacokinetic parameters to investigate the key factors involved in determining individual exposures to parent drugs and metabolites [ Designated as safety issue: No ]
Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on event-free survival [ Designated as safety issue: No ]
Influence of pharmacokinetic parameters and genotype for metabolizing enzyme on toxicity [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897871 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluating the Side Effects and How Well Anticancer Drugs Work in Very Young Patients With Cancer

Official Title ^ICMJE

Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from young patients with cancer may help doctors learn how carboplatin, cyclophosphamide, and etoposide affect the body and how patients will respond to treatment.

PURPOSE: This laboratory study is evaluating the side effects and how well anticancer drugs work in very young patients with cancer.

Detailed Description

OBJECTIVES:

Investigate inter-individual variability in the pharmacokinetics of selected anticancer drugs in infants and children age < 2 years on current dosing schedules.
Compare drug exposures and degree of pharmacokinetic variability in children < 2 years with data obtained from published studies in older children.
Relate inter-individual variability in pharmacokinetics and drug exposure to clinical toxicity and response.
Use pharmacokinetic data in conjunction with clinical information obtained following treatment to investigate the suitability of current dosing regimens in infants and young children.

OUTLINE: This is a multicenter study. Patients are stratified according to age in months (0 to 6 vs 6 to 12 vs 12 to 24).

Patients receive carboplatin, cyclophosphamide, or etoposide according to the dosing regimen detailed in the clinical protocol on which the child is being treated.

Blood samples are collected from patients receiving 1 of the 3 drugs by central venous catheter periodically during treatment to measure pharmacokinetics of the specific drug. Additional blood samples are collected for DNA extraction and polymorphism analysis in CYP2B6, CYP2C9, and other metabolizing enzymes in addition to the determination of the genetic variation in multiple drug resistance.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Biospecimen

Sampling Method

Study Population

Condition ^ICMJE

Unspecified Childhood Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide phosphate
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: pharmacological study

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of childhood cancer
Receiving carboplatin, cyclophosphamide, or etoposide as standard treatment as part of a clinical study at a Children's Cancer and Leukemia Group (CCLG) center

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Single or double lumen central venous catheter in place
No concurrent anticonvulsants, azole antifungal agents, or chronic steroid treatment

Gender

Both

Ages

up to 2 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Ireland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00897871

Other Study ID Numbers ^ICMJE

CDR0000560121, CCLG-PK-2006-09, EU-20742, EUDRACT-2006-002845-36

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Children's Cancer and Leukaemia Group

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gareth Veal

University of Newcastle Upon-Tyne

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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