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

Study Overview
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Brief Summary
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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.

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

Conditions
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Genital Neoplasms, Male

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j|
|Drug: Cisplatin|Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate objective response rate |  | until desease progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate tolerance of the association, |  | during all participation of the subject | 
| time to progression, |  | untill progression | 
| global survival |  | untill death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genital Neoplasms, Male