VinCaP

VinCaP is a phase II, multicentre, non-randomised trial of Vinflunine chemotherapy in locally-advanced and metastatic carcinoma of the Penis. 22 evaluable participants will be recruited from 9 centres and all patients will receive 4 cycles of IV vinflunine 320mg/m2 on day 1, to be repeated at intervals of 21 days. The primary endpoint, determined by RECIST v1.1, is clinical benefit (objective response + stable disease rate) measured after four cycles of vinflunine chemotherapy. Secondary endpoints are objective response rate (CR+PR), toxicity, progression-free survival, overall survival and treatment compliance. Formalin fixed paraffin embedded (FFPE) tumour blocks are held at the Orchid Tissue Laboratory and Barts and The London School of Medicine and Dentistry.