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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance \< 60ml/min).
All the current interventions used by each institution for the study disease.
Hospital General de Elda Virgen de la Salud
Elda, Alicante, Spain
ICO-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Progression Free Survival.
To evaluate the Progression Free Survival (PFS) with vinflunine in maintenance monotherapy in patients with advanced or metastatic CCTU that has reached stabilization or objective response after completing 6 cycles with the combination cisplatin-gemcitabine in 1st line.
Time frame: 1 year
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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
Alcorcón, 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
...and 10 more locations