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Brief Title: Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma
Official Title: Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression
Study ID: NCT01828736
Brief Summary: A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cliniques saint Luc - Université Catholique de Louvain, Bruxelles, , Belgium
CHU de Besançon, Besançon, , France
CHU Hôpital Saint André, Bordeaux, , France
Hôpital Jean Perrin, Clermont Ferrand, , France
Centre Hospitalier Départemental de la Vendée, La Roche-sur-yon, , France
Clinique Victor Hugo, Le Mans, , France
CHU Hôpital La Timone, Marseille, , France
Institut Paoli Calmettes, Marseille, , France
Clinique Hartmann, Neuilly-Sur-Seine, , France
Curie Institute, Paris, , France
Hôpital Saint Louis, Paris, , France
Groupe Hospitalier Saint Joseph Paris, Paris, , France
Hôpital Cochin, Paris, , France
Hôpital Européen Georges Pompidou, Paris, , France
Hôpital Foch, Suresnes, , France
Name: Stéphane Oudard, MD, PhD.
Affiliation: Hôpital Européen Georges Pompidou, Paris (France)
Role: PRINCIPAL_INVESTIGATOR
Name: Philippe Beuzeboc, MD
Affiliation: Curie Institute
Role: PRINCIPAL_INVESTIGATOR