Spots Global Cancer Trial Database for Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
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Trial Identification
Brief Title: Tolerance and Pharmacokinetics With Capecitabine 5 Out of 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
Study ID: NCT00324610
Interventions
Study Description
Brief Summary: 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Ho¨Pital Europeen Georges Pompidou, Paris, , France
Contact Details
Name: eric levy, MD
Affiliation: HEGP , PARIS
Role: PRINCIPAL_INVESTIGATOR
Name: joseph Gligorov, MD
Affiliation: HOPITAL TENON, PARIS
Role: STUDY_CHAIR
Name: Michèle TUBIANA HULIN, MD
Affiliation: CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE
Role: STUDY_CHAIR
Name: VERONIQUE DIERAS, MD
Affiliation: INSTITUT CURIE, PARIS france
Role: STUDY_CHAIR
Name: Rémi LARGILLIER, MD
Affiliation: centre antoine lacassagne, NICE, France
Role: STUDY_CHAIR
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