Trial Information

Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas

OBJECTIVES:

Primary

- To determine the ability of cytidine deaminase (CDA) to predict the occurrence of early
(during the first 2 courses) severe hematological toxicity (grade 3 or 4), induced by
gemcitabine hydrochloride in patients with resected pancreatic adenocarcinoma.

Secondary

- To determine the ability of CDA to predict the occurrence of severe non-hematological
toxicity (grade 3 or 4), early (during the first 2 courses), and during the following
courses, induced by gemcitabine hydrochloride.

- To determine the ability of CDA to predict the occurrence of severe hematological
toxicity (grade 3 or 4) during all courses, induced by gemcitabine hydrochloride.

- To determine the impact of CDA status on gemcitabine hydrochloride pharmacokinetics and
the ratio of gemcitabine hydrochloride/dFdU metabolization.

- To study genotype to phenotype of the CDA gene.

- To identify new mutations on the CDA gene.

- To evaluate the relationship between CDA status and global survival. (Exploratory)

OUTLINE: This is a multicenter study.

Within 8 weeks of resection, patients receive adjuvant gemcitabine hydrochloride IV over 30
minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 6 courses in the absence
of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacogenetic and biomarker studies. Some
patients may undergo blood sample collection for pharmacokinetic studies.

After completion of study, patients are followed up periodically.