Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Recruitment status was: Recruiting
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity.
Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen.
Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen
|Official Title:||Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324610
|Ho¨Pital Europeen Georges Pompidou|
|Paris, France, 75015|
|Principal Investigator:||eric levy, MD||HEGP , PARIS|
|Study Chair:||joseph Gligorov, MD||HOPITAL TENON, PARIS|
|Study Chair:||Michèle TUBIANA HULIN, MD||CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE|
|Study Chair:||VERONIQUE DIERAS, MD||INSTITUT CURIE, PARIS france|
|Study Chair:||Rémi LARGILLIER, MD||centre antoine lacassagne, NICE, France|