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

Phase 1
18 Years
Open (Enrolling)

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Trial Information

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:


Outcome Time Frame:

during fluoropyrimidine treatment of the patient

Safety Issue:


Principal Investigator

Jan HM Schellens, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Netherlands Cancer Institute, Amsterdam, the Netherlands


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

May 2007

Completion Date:

August 2009

Related Keywords:

  • Neoplasms
  • Pharmacogenetics
  • cost-benefit analysis
  • toxicity
  • antineoplastic drugs
  • Dihydropyrimidine Dehydrogenase
  • Neoplasms