Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
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|ClinicalTrials.gov Identifier: NCT00324610|
Recruitment Status : Unknown
Verified May 2006 by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie.
Recruitment status was: Recruiting
First Posted : May 11, 2006
Last Update Posted : May 18, 2006
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Chemotherapy||Drug: capecitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||46 participants|
|Official Title:||Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer|
|Study Start Date :||March 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324610
|Contact: eric levy, firstname.lastname@example.org|
|Contact: kahina rideller, CRAemail@example.com|
|Ho¨Pital Europeen Georges Pompidou||Recruiting|
|Paris, France, 75015|
|Contact: ERIC LEVY, MD 33-1-56092985 firstname.lastname@example.org|
|Sub-Investigator: jacques medioni, MD|
|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|