Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma

Phase 2 Completed 50 enrolled Institut Claudius Regaud

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.

Timeline

Start: 2004-02
Primary completion: 2011-12
Completion: 2012-12

Outcome

Missed primary endpoint

paper Every 2 weeks' administration of the combination of gemcitabine and cisplatin showed non-significant responses in patients with unresected locoregional or metastatic penile SCC. PMID 25601543 ↗

paper Despite manageable side-effects, this combination cannot be recommended as a standard of care, due to disappointing response rates seen in this negative study. PMID 25601543 ↗

Publications

Results Houede N, Dupuy L, Flechon A, Beuzeboc P, Gravis G, Laguerre B, Theodore C, Culine S, Filleron T, Chevreau C. Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma. BJU Int. 2016 Mar;117(3):444-9. doi: 10.1111/bju.13054. Epub 2015 Apr 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	50 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous