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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Claudius Regaud
• Treatments: Cisplatin; Gemcitabine

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.