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

Sponsor
Institut Claudius Regaud (Other)
Overall Status
Completed
CT.gov ID
NCT00210041
Collaborator
(none)
50
Enrollment
11
Locations
106
Duration (Months)
4.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2004
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2012

Outcome Measures

Primary Outcome Measures

  1. To evaluate objective response rate [until desease progression]

Secondary Outcome Measures

  1. To evaluate tolerance of the association, [during all participation of the subject]

  2. time to progression, [untill progression]

  3. global survival [untill death]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Paul Papin Angers France
2 Institut Bergonie Bordeaux France
3 Centre François Baclesse Caen France
4 CHU Grenoble Grenoble France
5 Centre Léon Bérard Lyon France
6 Institut Paoli Calmette Marseille France
7 Institut Val d'aurelle Montpellier France
8 Institut Curie Paris France
9 Centre Eugène Marquis Rennes France
10 Centre Médico-Chirurgical Foch Suresnes France
11 Institut Claudius Regaud Toulouse France

Sponsors and Collaborators

  • Institut Claudius Regaud

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00210041
Other Study ID Numbers:
  • 03 GENH 06
  • 02 GENM 02
First Posted:
Sep 21, 2005
Last Update Posted:
Mar 31, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Institut Claudius Regaud
Genital Neoplasms, Male
Additional relevant MeSH terms:
Genital Neoplasms, Male
Carcinoma, Squamous Cell
Gemcitabine

Study Results

No Results Posted as of Mar 31, 2015