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Retrospective Analysis of Drug Disposition and Response-related Genotypes in Cancer Patients and Correlation With Pharmacokinetics and Pharmacodynamics Data


Phase 1
18 Years
N/A
Open (Enrolling by invite only)
Both
Cancer

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Trial Information

Retrospective Analysis of Drug Disposition and Response-related Genotypes in Cancer Patients and Correlation With Pharmacokinetics and Pharmacodynamics Data


Background

Genetic polymorphisms in drug-metabolizing enzymes, transporter/receptors, and transcription
factors might affect an individual's response to drug therapy.

Interindividual differences in efficacy and toxicity of cancer chemotherapy are especially
important given the narrow therapeutic index of these drugs.

During analysis of investigational agents, interindividual variances in pharmacokinetics and
pharmacodynamics are often noted. It is often wondered if these variances might in part be
explained by genetic differences in drug metabolizing enzymes, transporters.

Objectives

To better understand the genotype-phenotype relationship, additional analysis correlating
pharmacokinetic data with relevant genotyping.

Eligibility

All individuals previously enrolled on IRB approved clinical trials at the National Cancer
Institute.

Design

In these retrospective studies, the association between an individual's pharmacokinetic
profile and the genetic variation in their drug metabolizing enzymes and other critical
regulators of gene expression will be investigated.

The hypothesis that an individual's genotypic constitution may be associated with clinical
response and/or toxicity will be explored.

Inclusion Criteria


- INCLUSION CRITERIA:

In this retrospective study, any cancer patients entered on IRB approved clinical trials
at the National Cancer Institute are eligible. Studies for which pharmacokinetic analyses
were/are being performed will be the source of the patient population. At this time
enrollment will be limited to patients with pharmacokinetic samples obtained during
treatment on protocol 00-C-0033, 00-C-0080, 01-C-0049, 01-C-0124, 01-C-0215, 02-C-0061,
02-C-0083, 02-C-0130, 02-C-0149, 02-C-0215, 02-C-0218, 02-C-0229, 03-C-0030, 03-C-0157,
03-C-0176, 03-C-0284, 04-C-0132, 04-C-0257, 04-C-0262, 04-C-0273, 04-C-0280, 05-C-0022,
05-C-0049, 05-C-0167, 05-C-0186, 06-C-0083, 06-C-0088, 06-C-0164, 06-C-0221, 07-C-0047,
07-C-0059, 07-C-0106, 07-C-0107, 08-C-0030, 08-C-0074, 94-C-0169, 95-C-0015, 97-C-0135,
97-C-0171, and 98-C-0015.

EXCLUSION CRITERIA:

A patient will be excluded if there is an insufficient quantity of sample available to
perform the genotyping procedure. This is not anticipated to be of significance for this
study since the methodology does not require a large serum sample.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

William D Figg, Pharm.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999904279

NCT ID:

NCT00341939

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Cancer
  • Polymorphism
  • Toxicity
  • Chemotherapy
  • Clearance
  • Cytochrome P450

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892