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

Primary Purpose

Genital Neoplasms, Male

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gemcitabine
Cisplatin
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Neoplasms, Male focused on measuring Genital Neoplasms, Male

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Paul Papin
  • Institut Bergonie
  • Centre François Baclesse
  • CHU Grenoble
  • Centre Léon Bérard
  • Institut Paoli Calmette
  • Institut Val d'aurelle
  • Institut Curie
  • Centre Eugène Marquis
  • Centre Médico-Chirurgical Foch
  • Institut Claudius Regaud

Outcomes

Primary Outcome Measures

To evaluate objective response rate

Secondary Outcome Measures

To evaluate tolerance of the association,
time to progression,
global survival

Full Information

First Posted
September 2, 2005
Last Updated
March 26, 2015
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT00210041
Brief Title
Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
Official Title
Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Neoplasms, Male
Keywords
Genital Neoplasms, Male

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemzar IV infusion 30 minutes Day 1/ Day 15 1250 mg/m²/j
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 50 mg/m²/day 1 h IV infusion at Day 1 / Day 15
Primary Outcome Measure Information:
Title
To evaluate objective response rate
Time Frame
until desease progression
Secondary Outcome Measure Information:
Title
To evaluate tolerance of the association,
Time Frame
during all participation of the subject
Title
time to progression,
Time Frame
untill progression
Title
global survival
Time Frame
untill death

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Chevreau, Doctor
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Facility Name
Centre François Baclesse
City
Caen
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
Country
France
Facility Name
Institut Val d'aurelle
City
Montpellier
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Centre Médico-Chirurgical Foch
City
Suresnes
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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