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

March 26, 2015 updated by: Institut Claudius Regaud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Centre Paul Papin
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France
        • Centre Francois Baclesse
      • Grenoble, France
        • CHU Grenoble
      • Lyon, France
        • Centre LEON BERARD
      • Marseille, France
        • Institut Paoli Calmette
      • Montpellier, France
        • Institut Val d'aurelle
      • Paris, France
        • Institut Curie
      • Rennes, France
        • Centre Eugene Marquis
      • Suresnes, France
        • Centre Médico-Chirurgical Foch
      • Toulouse, France
        • Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate objective response rate
Time Frame: until desease progression
until desease progression

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate tolerance of the association,
Time Frame: during all participation of the subject
during all participation of the subject
time to progression,
Time Frame: untill progression
untill progression
global survival
Time Frame: untill death
untill death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Christine Chevreau, Doctor, Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03 GENH 06
  • 02 GENM 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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