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