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

Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin

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.

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.

Exclusion Criteria:

• Uncontrolled cerebral known metastasis
• All former chemotherapy administration during 5 years between inclusion
• Other cancer (except baso-cellular cancer of skin correctly treated, or cancerous disease considered with good prognosis and on remission until 5 years at least)
• Uncontrolled cardiac insufficiency or all other severe and uncontrolled pathology.
• Peripheric neuropathy ≥ grade 2 OMS
• Anormal audiogram
• Patient difficult to follow for geographical, psychological or family reasons.
• Persons protected by law.