Carcinoma, Transitional Cell Clinical Trial
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
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).
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