Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01416662
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2011-08-12
Brief Title:
Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
Pharmacogenetics of Gemcitabine Study of the Impact of Genetic Polymorphism of Cytidine Deaminase CDA on Toxicity in Resected Pancreatic Adenocarcinomas
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery
Detailed Description:
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 hydrochloridedFdU 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
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 hydrochloridedFdU 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FFCD-1004 | None | None | None |
| EU-21118 | None | None | None |
| EUDRACT-2010-022987-11 | None | None | None |