Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
Phase 2
Completed
- Conditions
- Genital Neoplasms, Male
- Registration Number
- NCT00210041
- Lead Sponsor
- Institut Claudius Regaud
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate objective response rate until desease progression
- Secondary Outcome Measures
Name Time Method global survival untill death To evaluate tolerance of the association, during all participation of the subject time to progression, untill progression
Trial Locations
- Locations (11)
Centre Paul Papin
🇫🇷Angers, France
Centre François Baclesse
🇫🇷Caen, France
Institut Bergonie
🇫🇷Bordeaux, France
CHU Grenoble
🇫🇷Grenoble, France
Institut Val d'aurelle
🇫🇷Montpellier, France
Centre Léon Bérard
🇫🇷Lyon, France
Institut Paoli Calmette
🇫🇷Marseille, France
Institut Curie
🇫🇷Paris, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Médico-Chirurgical Foch
🇫🇷Suresnes, France
Centre Eugène Marquis
🇫🇷Rennes, France