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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210041
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 31, 2015
Information provided by (Responsible Party):
Institut Claudius Regaud

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.

Condition or disease Intervention/treatment Phase
Genital Neoplasms, Male Drug: Gemcitabine Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
Study Start Date : February 2004
Primary Completion Date : December 2011
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. To evaluate objective response rate [ Time Frame: until desease progression ]

Secondary Outcome Measures :
  1. To evaluate tolerance of the association, [ Time Frame: during all participation of the subject ]
  2. time to progression, [ Time Frame: untill progression ]
  3. global survival [ Time Frame: untill death ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210041

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, France
Sponsors and Collaborators
Institut Claudius Regaud
Principal Investigator: Christine Chevreau, Doctor Institut Claudius Regaud

Responsible Party: Institut Claudius Regaud Identifier: NCT00210041     History of Changes
Other Study ID Numbers: 03 GENH 06
02 GENM 02
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Institut Claudius Regaud:
Genital Neoplasms, Male

Additional relevant MeSH terms:
Genital Neoplasms, Male
Carcinoma, Squamous Cell
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs