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Sponsored by: |
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie |
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Information provided by: | Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie |
ClinicalTrials.gov Identifier: | NCT00324610 |
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 | Intervention | Phase |
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Breast Neoplasms Chemotherapy |
Drug: capecitabine |
Phase I Phase II |
Study Type: | Interventional |
Official Title: | Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: eric levy, md | 33-1-56092985 | eric.levy@egp.aphp.fr |
Contact: kahina rideller, CRA | 33-1-56093433 | kahina.rideller@egp.aphp.fr |
France | |
Ho¨Pital Europeen Georges Pompidou | Recruiting |
PARIS, France, 75015 | |
Contact: ERIC LEVY, MD 33-1-56092985 eric.levy@egp.aphp.fr | |
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 |
Study ID Numbers: | CAP 5/7, ARTIC / CAP 5/7 |
Study First Received: | May 9, 2006 |
Last Updated: | May 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00324610 |
Health Authority: | France: Comité National d'Ethique |
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