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


Phase 2
18 Years
N/A
Not Enrolling
Male
Genital Neoplasms, Male

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate objective response rate

Outcome Time Frame:

until desease progression

Safety Issue:

No

Principal Investigator

Christine Chevreau, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

03 GENH 06

NCT ID:

NCT00210041

Start Date:

February 2004

Completion Date:

September 2012

Related Keywords:

  • Genital Neoplasms, Male
  • Genital Neoplasms, Male
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Genital Neoplasms, Male

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