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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease control rate as defined by RECIST criteria (version 1.1) as a percentage of best overall responses of Complete (CR) + Partial (PR) + Stable Disease (SD) for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations
Assessment of lesions (measurable and non-measurable) should be performed at baseline and every 6 weeks (assessment interval). Evaluable patients: all baseline lesions must have been assessed at least once after the second cycle (6 weeks); patients who progress before the first evaluation will be considered as early progression. Primary analysis is planned on the intent to treat population, secondary analysis being performed on the evaluable population.
Change from baseline in tumor assessment at 12 weeks (cycle 4)
No
Maria De Santis, MD
Principal Investigator
Center for Oncology and Hematology Kaiser Franz Josef Hospital - Vienna - Austria
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
L00070 IN 213 P1
NCT01599013
February 2011
April 2013
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