Clinical trial NCT00210041: Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
Official title: Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Genital Neoplasms, Male
Keywords: Genital Neoplasms, Male
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: To evaluate objective response rate
timeFrame: until desease progression
Secondary outcomes:
measure: To evaluate tolerance of the association,
timeFrame: during all participation of the subject
measure: time to progression,
timeFrame: untill progression
measure: global survival
timeFrame: untill death
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre François Baclesse
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: Institut Val d'aurelle
city: Paris
country: France
facility: Institut Curie
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Suresnes
country: France
facility: Centre Médico-Chirurgical Foch
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Christine Chevreau, Doctor
role: PRINCIPAL_INVESTIGATOR
References: