Status:
COMPLETED
Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines
Lead Sponsor:
The Netherlands Cancer Institute
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 h...
Detailed Description
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 dev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00838370
Start Date
May 1 2007
End Date
October 1 2011
Last Update
March 4 2014
Active Locations (3)
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1
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066CX
2
Slotervaart Hospital
Amsterdam, Netherlands, 1066
3
Canisius Wilhelmina Hospital
Nijmegen, Netherlands, 6532SZ