Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
This study is currently recruiting participants.
Verified by Institut Claudius Regaud, November 2006
Sponsored by: Institut Claudius Regaud
Information provided by: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00210041
  Purpose

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.


Condition Intervention Phase
Genital Neoplasms, Male
Drug: Gemcitabine
Drug: Cisplatin
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-Regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • To evaluate objective response rate

Secondary Outcome Measures:
  • To evaluate tolerance of the association,
  • time to progression,
  • global survival

Estimated Enrollment: 50
Study Start Date: February 2004
Estimated Study Completion Date: September 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210041

Contacts
Contact: Christine CHEVREAU, Doctor +33 5.61.42.41.18 Chevreau.Christine@claudiusregaud.fr

Locations
France
Institut Claudius Regaud Recruiting
Toulouse, France
Contact: Christine Chevreau, Doctor     +33 5.59.42.41.18     Chevreau.Christine@claudiusregaud.fr    
Sub-Investigator: Florence Dalenc, Doctor            
Sub-Investigator: Jean Pierre Delord, Doctor            
Sub-Investigator: Loic Mourey, Doctor            
Centre Paul Papin Recruiting
Angers, France
Contact: R. Delva, Dr            
Institut Bergonie Recruiting
Bordeaux, France
Contact: N. Tchen, Dr            
Centre François Baclesse Recruiting
Caen, France
Contact: E. Sevin, Dr            
Institut Curie Recruiting
Paris, France
Contact: P. Beuzeboc, Dr            
Centre Médico-Chirurgical Foch Recruiting
Suresnes, France
Contact: L. Mignot, Dr            
Centre Léon Bérard Recruiting
Lyon, France
Contact: A. Flechon, Dr            
Institut Paoli Calmette Recruiting
Marseille, France
Contact: G. Gravis, Dr            
Institut Val d'aurelle Recruiting
Montpellier, France
Contact: S. Culine, Dr            
Centre Eugène Marquis Recruiting
Rennes, France
Contact: Kerbrat, Dr            
CHU Grenoble Recruiting
Grenoble, France
Contact: N. Tchen, Dr            
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Christine Chevreau, Doctor Institut Claudius Regaud
  More Information

Study ID Numbers: 03 GENH 06, 02 GENM 02
Study First Received: September 2, 2005
Last Updated: November 10, 2006
ClinicalTrials.gov Identifier: NCT00210041  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Claudius Regaud:
Genital Neoplasms, Male

Study placed in the following topic categories:
Epidermoid carcinoma
Cisplatin
Genital Neoplasms, Male
Squamous cell carcinoma
Carcinoma, squamous cell
Urogenital Neoplasms
Neoplasms, Squamous Cell
Gemcitabine
Genital Diseases, Male
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009