VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis.

ABSTRACT:

Background

We investigated the first-line activity of vinflunine in patients with penis cancer. Cisplatin-based combinations are commonly used, but survival is not prolonged; many patients are unfit for such treatment or experience toxicity that outweighs clinical benefit.

Methods

Twenty-five patients with inoperable squamous carcinoma of the penis were recruited to a single-arm, Fleming-A'Hern exact phase II trial. Treatment comprised 4 cycles of vinflunine 320 mg/m², given every 21 days. Primary endpoint was clinical benefit rate (CBR: objective responses plus stable disease) assessed after 4 cycles. Seven or more objective responses or disease stabilisations observed in 22 evaluable participants would exclude a CBR of <15%, with a true CBR of >40% being probabl

SUBMITTER: Nicholson S 

PROVIDER: S-EPMC8727613 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature