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

Inclusion Criteria

• •Age ≥ 18 years
• •OMS ≤ 2
• •Penis epidermoid carcinoma histologically proved. Tumor with ganglionic loco-regional injury inextirpable and/or metastatic (M1, all T , all N), at initial diagnostic or at relapse after first treatment with curative aim (surgery and / or radiotherapy)
• •Disease measurable with RECIST criteria
• •Absence of all former chemotherapy during 5 years between inclusion.
• •If former radiotherapy, necessity to have appreciated targets outside the irradiation fields. If former radiotherapy, it must have been done more than 4 weeks before inclusion in the study.
• •Biologicals values required : polynuclear neutrophils ≥ 1500/mm3, blood-platelets ≥ 100000/mm3, Hb ≥ 10 g/dl, Transaminases \< 3N, TP ≥ 70%, total bilirubin \< 1,5 N, creatinine in the blood ≤ 110 micromoles/l.
• •Normal clearance of creatinine, according to Cockroft and Gault's formulae.
• •Calcemia : normal or anomaly without clinical meaning.
• •Well-informed written consent, signed by the patient.