Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas|
- capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||September 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416662
|CHU de la Timone|
|Marseille, France, 13385|
|Principal Investigator:||Laetitia Dahan, MD||CHU de la Timone|