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

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Neoplasms
Interventions
DRUG

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."

Trial Locations (3)

1066

Slotervaart Hospital, Amsterdam

1066CX

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam

6532SZ

Canisius Wilhelmina Hospital, Nijmegen

All Listed Sponsors
lead

The Netherlands Cancer Institute

OTHER

NCT00838370 - Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines | Biotech Hunter | Biotech Hunter