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

This study has suspended participant recruitment.
(interim analysis)
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00210041
First received: September 2, 2005
Last updated: November 23, 2011
Last verified: November 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • To evaluate objective response rate [ Time Frame: until desease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate tolerance of the association, [ Time Frame: during all participation of the subject ] [ Designated as safety issue: Yes ]
  • time to progression, [ Time Frame: untill progression ] [ Designated as safety issue: No ]
  • global survival [ Time Frame: untill death ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2004
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210041

Locations
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, France
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Christine Chevreau, Doctor Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00210041     History of Changes
Other Study ID Numbers: 03 GENH 06, 02 GENM 02
Study First Received: September 2, 2005
Last Updated: November 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Genital Neoplasms, Male

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

ClinicalTrials.gov processed this record on November 25, 2014