Bladder Transitional Cell Carcinoma Stage IV Clinical Trial
Official title:
Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.
Gemcitabine and carboplatin have been the most studied and used anticancer agents in
cisplatin-unfit patients with advanced urothelial carcinoma. Both agents previously
demonstrated clinical activity as single agent and/or as part of combination regimen in
patients with advanced or metastatic disease even if clinical benefits and survival remains
limited in this setting for this population.
The purpose of this study is to test in a randomized trial enrolling patients with renal
impairment or moderate congestive heart failure two combinations of a novel cytotoxic agent,
vinflunine, one with gemcitabine and another with carboplatin in order to determine the most
promising combination in the first line treatment of advanced/metastatic urothelial
carcinoma.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment