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

Institut Claudius Regaud

Status and phase

Completed

Phase 2

Conditions

Genital Neoplasms, Male

Treatments

Drug: Gemcitabine

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00210041

02 GENM 02

03 GENH 06

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.