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Brief Title: Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer
Official Title: Randomized Phase II Study of Vinflunine as Maintenance Monotherapy in Patients With Advanced or Metastatic Urothelial Cancer That Obtains Clinical Benefit of the First Line With Cisplatin-gemcitabine Combination
Study ID: NCT01529411
Brief Summary: This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine administered after the standard treatment of the combination gemcitabine+cisplatin, when it has reached stabilization or response of the disease, as the first treatment inmeditely after the diagnosis of advanced or metastatic urothelial cancer.
Detailed Description: Vinflunine is a drug recently approved in Europe for the treatment of advanced or metastatic urothelial cancer after platinum-failure. It has proved to improve the survival results compared with the best suportive care. In adition, the tolerability was favourable, specially for not leading appearance of neuropathy nor other cumulative toxic effects. In this study, it is proposed to test the feasibility, in terms of tolerability and efficacy of monotherapy with vinflunine in patients who, after completing the first-line cisplatin-based treatment for Transitional Cell Carcinoma of the Urothelial Tract (CCTU), have reached a stabilization or objective response. In order to have an adequate control group in the proposed design will be a phase II trial in which one group will receive standard management (follow-up until progression disease).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital General de Elda Virgen de la Salud, Elda, Alicante, Spain
ICO-Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
ICO-Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Fundació Althaia, Manresa, Barcelona, Spain
Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain
Complejo Hosp. Univ. de Santiago de Compostela, Santiago de Compostela, Galicia, Spain
Hospital Universitario Fundación Alcorcón, Alcorcon, Madrid, Spain
H. del Mar (Fundació Institut Mar d´Investigacions Mèdiques - FIMIM), Barcelona, , Spain
H. Universitari Vall d'Hebrón, Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
H. General Universitario de Ciudad Real, Ciudad Real, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitari Son Espases, Palma de Mallorca, , Spain
Clínica Universitaria de Navarra (CUN), Pamplona, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
H. Universitario Virgen de la Macarena, Sevilla, , Spain
H. Universitario Virgen del Rocío, Sevilla, , Spain
IVO, Valencia, , Spain
Name: Jesús García-Donas, MD
Affiliation: Hospital Universitario Fundación Alcorcón
Role: PRINCIPAL_INVESTIGATOR
Name: Albert Font, MD
Affiliation: ICO-Hospital Universitari Germans Trias i Pujol
Role: PRINCIPAL_INVESTIGATOR
Name: Joaquim Bellmunt, MD
Affiliation: H. del Mar - FIMIM (Fundació Institut Mar d´Investigacions Mèdiques)
Role: PRINCIPAL_INVESTIGATOR