Genital Neoplasms, Male
Conditions
Keywords
Genital Neoplasms, Male
Brief 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.
Interventions
DRUGGemcitabine
Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
DRUGCisplatin
Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15
Sponsors
Institut Claudius Regaud
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate objective response rate | until desease progression |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate tolerance of the association, | during all participation of the subject |
| time to progression, | untill progression |
| global survival | untill death |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristine Chevreau, Doctor
Institut Claudius Regaud
Outcome results
None listed