Status:
COMPLETED
Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Genital Neoplasms, Male
Eligibility:
MALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00210041
Start Date
February 1 2004
End Date
December 1 2012
Last Update
March 31 2015
Active Locations (11)
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1
Centre Paul Papin
Angers, France
2
Institut Bergonie
Bordeaux, France
3
Centre François Baclesse
Caen, France
4
CHU Grenoble
Grenoble, France