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

Genital Neoplasms, Male Clinical Trial

Official title:

Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210041
• Other study ID #: 03 GENH 06
• Secondary ID: 02 GENM 02
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: March 26, 2015
• Start date: February 2004
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Genital Neoplasms, Male

Intervention

Drug:
• Gemcitabine
Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
• Cisplatin
Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Institut Bergonie	Bordeaux
France	Centre François Baclesse	Caen
France	CHU Grenoble	Grenoble
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmette	Marseille
France	Institut Val d'aurelle	Montpellier
France	Institut Curie	Paris
France	Centre Eugène Marquis	Rennes
France	Centre Médico-Chirurgical Foch	Suresnes
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate objective response rate		until desease progression	No
Secondary	To evaluate tolerance of the association,		during all participation of the subject	Yes
Secondary	time to progression,		untill progression	No
Secondary	global survival		untill death	No