Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥ 75 Years) (capagec)
The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years)|
- Mean value and dispersion of the main plasmatics pharmacokinetics parameters of capécitabine, 5'DFUR, 5-FU and FBAL. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Adverse effects evaluation after every course of chemotherapy according to NCI criteria during 6 courses maximum. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Objective response comparing lesions' targets according to RECIST criteria, at course n°3 and n°6. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Quality of life. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Pharmacokinetic of its metabolites.
Capecitabine, 1250 mg/m2 twice a day
Blood samples will be taken before 1rst course of chemotherapy of capécitabine for colorectal or breast metastatic cancer.
Pharmacokinetic will be realizes at several times (H0,5, H1, H1,5, H2, H4, H6, H8) and repeated at D14 of the 2d cycle
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812864
|Limoges Cedex, Province, France, 87042|
|Principal Investigator:||Nicole TUBIANA-MATHIEU, MD||CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France|