Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-10-31

Brief Summary

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The primary purpose of this study is to prospectively determine whether capecitabine and 5-FU-induced toxicity is preventable by dose reduction prior to start of the first administration in patients heterozygous or homozygous mutant for DPYD\*2A, and to determine whether this strategy is cost-effective. Secondly, an individualized treatment algorithm for capecitabine and 5-FU therapy in DPYD\*2A mutant patients will be developed and the pharmacokinetic profile of capecitabine and 5-FU will be assessed.

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Detailed Description

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Patients exhibiting a genetically determined disorder (DPYD\*2A) in the metabolic degradation of the frequently used anticancer agents capecitabine and 5-FU (fluoropyrimidines) are at high risk of development of severe and life-threatening toxicity during standard treatment with these compounds. Treatment and recovery of this fluoropyrimidine-induced severe toxicity often requires prolonged periods of hospitalization.

Screening for DPYD\*2A in patients to treat with fluoropyrimidine drugs with subsequent dose adjustments in mutant individuals prior to start of therapy will possibly reduce the number of severe toxicity events. Furthermore, by reducing the frequency and/or duration of hospitalization, substantial medical costs can be saved, making this a cost-effective strategy.

Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DPYD*2A

Patients are screened for a DPD-deficiency. Patients with a DPYD\*2A mutation are eligible for intervention with capecitabine/5-FU .

Group Type EXPERIMENTAL

Capecitabine, 5-fluorouracil

Intervention Type DRUG

Patients to treat with capecitabine/5-FU will be screened prior to start of therapy for DPYD\*2A. Patients heterozygous or homozygous mutant for DPYD\*2A receive dose reductions of capecitabine/5-FU of at least 50% in the first two courses. In case this dose is tolerated well, doses will be increased.

In addition, the pharmacokinetics of capecitabine/5-FU and their metabolites will be assessed in these patients.

Interventions

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Capecitabine, 5-fluorouracil

Patients to treat with capecitabine/5-FU will be screened prior to start of therapy for DPYD\*2A. Patients heterozygous or homozygous mutant for DPYD\*2A receive dose reductions of capecitabine/5-FU of at least 50% in the first two courses. In case this dose is tolerated well, doses will be increased.

In addition, the pharmacokinetics of capecitabine/5-FU and their metabolites will be assessed in these patients.

Intervention Type DRUG

Other Intervention Names

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Xeloda Capecitabine Fluorouracil 5-Fluorouracil 5-FU

Eligibility Criteria

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Inclusion Criteria

* Histological proof of cancer
* patient is considered for treatment with capecitabine or 5-FU
* hetero- or homozygous mutant for DPYD\*2A
* able and willing to give written informed consent
* able and willing to undergo blood sampling for pharmacokinetic analysis
* life expectancy 3 months or longer
* acceptable safety laboratory values (ANC, platelet count, ASAT, ALAT, creatinine,
* WHO performance status 0-2
* no radio- or chemotherapy within the last 3 weeks prior to study entry

Exclusion Criteria

* patients with known alcoholism, drug addiction and/or psychotic disorders that are not suitable for adequate follow-up
* women who are pregnant or breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No