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

NCT00210041 | Completed Phase 2

• 2 other identifiers: 03 GENH 0602 GENM 02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

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.

Conditions

Genital Neoplasms, Male

Keywords

Genital Neoplasms, Male

Outcome Measures

Primary Outcomes (1)

• To evaluate objective response rate

  until desease progression

Secondary Outcomes (3)

• To evaluate tolerance of the association,

  during all participation of the subject

• time to progression,

  untill progression

• global survival

  untill death

Interventions

Gemcitabine DRUG

Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j

Cisplatin DRUG

Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Uncontrolled cerebral known metastasis
• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (11)

Centre Paul Papin

Angers, France

Location

Institut Bergonie

Bordeaux, France

Location

Centre François Baclesse

Caen, France

Location

CHU Grenoble

Grenoble, France

Location

Centre Léon Bérard

Lyon, France

Location

Institut Paoli Calmette

Marseille, France

Location

Institut Val d'aurelle

Montpellier, France

Location

Institut Curie

Paris, France

Location

Centre Eugène Marquis

Rennes, France

Location

Centre Médico-Chirurgical Foch

Suresnes, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Genital Neoplasms, Male

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Christine Chevreau, Doctor

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

FR (11)