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| Sponsor: | University Hospital, Limoges |
|---|---|
| Information provided by: | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT00812864 |
Purpose
The aim of the study is to determine blood concentration evolution of capecitabine and its active metabolites, in elderly patient 75 years and more.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colorectal Cancer |
Drug: Capecitabine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Pharmacokinetic Study of Capecitabine in Elderly Cancer Patient (≥75 Years) |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | May 2010 (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
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values :
Exclusion Criteria:
Contacts and Locations| Contact: Jean MARTIN, MD | 0555056396 | oncologie@chu-limoges.fr |
| France, Province | |
| CHU Limoges | Recruiting |
| Limoges Cedex, Province, France, 87042 | |
| Contact: Jean MARTIN, MD 0555056396 oncologie@chu-limoges.fr | |
| Contact: Jean MARTIN, MD 0555056396 oncologie@chu-limoges.fr | |
| Principal Investigator: Jean MARTIN, MD | |
| Principal Investigator: | jean MARTIN, MD | CHU de Limoges, medical oncology department ,02 avenue Martin Luther King 87042 Limoges cedex France |
More Information
| Responsible Party: | CHU de Limoges ( M.SENGELEN/Directrice de la Recherche clinique et de l'Innovation ) |
| Study ID Numbers: | I07028, N° EudraCT : 2008-001195-7 |
| Study First Received: | December 19, 2008 |
| Last Updated: | September 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00812864 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Capecitabine pharmacocinetics Breast metastatic cancer colorectal metastatic cancer Elderly patients |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Therapeutic Uses Breast Diseases Capecitabine |
Digestive System Neoplasms Skin Diseases Breast Neoplasms Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |