Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
Genital Neoplasms, Male
About this trial
This is an interventional treatment trial for Genital Neoplasms, Male focused on measuring Genital Neoplasms, Male
Eligibility Criteria
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.
Sites / Locations
- Centre Paul Papin
- Institut Bergonie
- Centre François Baclesse
- CHU Grenoble
- Centre Léon Bérard
- Institut Paoli Calmette
- Institut Val d'aurelle
- Institut Curie
- Centre Eugène Marquis
- Centre Médico-Chirurgical Foch
- Institut Claudius Regaud