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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2012-12-31

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.

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Detailed Description

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Conditions

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Genital Neoplasms, Male

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j

Intervention Type DRUG

Cisplatin

Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No