Overview

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

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut Claudius Regaud
Treatments:
Cisplatin
Gemcitabine
Criteria
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.