NCT00210041CompletedPhase 2
Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
Institut Claudius Regaud11 sites in 1 country50 target enrollmentStarted: February 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Institut Claudius Regaud
- Enrollment
- 50
- Locations
- 11
- Primary Endpoint
- To evaluate objective response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •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.
Outcomes
Primary Outcomes
To evaluate objective response rate
Time Frame: until desease progression
Secondary Outcomes
- global survival(untill death)
- To evaluate tolerance of the association,(during all participation of the subject)
- time to progression,(untill progression)
Investigators
Study Sites (11)
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