Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines
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|ClinicalTrials.gov Identifier: NCT00838370|
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : March 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: Capecitabine, 5-fluorouracil||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacogenomic and Pharmacokinetic Safety and Cost-saving Analysis in Patients Treated With Fluoropyrimidines|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Patients are screened for a DPD-deficiency. Patients with a DPYD*2A mutation are eligible for intervention with capecitabine/5-FU .
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.
- safety [ Time Frame: during fluoropyrimidine treatment of the patient ]
- cost-effectiveness [ Time Frame: during fluoropyrimidine treatment of the patient ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838370
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066CX|
|Amsterdam, Netherlands, 1066|
|Canisius Wilhelmina Hospital|
|Nijmegen, Netherlands, 6532SZ|
|Principal Investigator:||Jan HM Schellens, MD, PhD||Netherlands Cancer Institute, Amsterdam, the Netherlands|