Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)

Summary

Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.

Timeline

Start

2012-10

Primary completion

2016-11

Completion

2016-11

Publications

• Background Bellmunt J, Choueiri TK, Fougeray R, Schutz FA, Salhi Y, Winquist E, Culine S, von der Maase H, Vaughn DJ, Rosenberg JE. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol. 2010 Apr 10;28(11):1850-5. doi: 10.1200/JCO.2009.25.4599. Epub 2010 Mar 15.
• Bellmunt J, Kerst JM, Vazquez F, Morales-Barrera R, Grande E, Medina A, Gonzalez Graguera MB, Rubio G, Anido U, Fernandez Calvo O, Gonzalez-Billalabeitia E, Van den Eertwegh AJM, Pujol E, Perez-Gracia JL, Gonzalez Larriba JL, Collado R, Los M, Macia S, De Wit R; SOGUG and DUOS. A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN). Ann Oncol. 2017 Jul 1;28(7):1517-1522. doi: 10.1093/annonc/mdx186.

Drugs

Indications