Clinical trial · Interventional
Phase 2 Study of Association Gemcitabine-Cisplatin to Treat Penis Epidermoid Carcinoma
Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
NCT00210041CI-TRIAL-00111677completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasms, Male | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate objective response rate
- timeFrame
- until desease progression
Secondary outcomes (3)
- measure
- To evaluate tolerance of the association,
- timeFrame
- during all participation of the subject
- measure
- time to progression,
- timeFrame
- untill progression
- measure
- global survival
- timeFrame
- untill death
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHouede N, Dupuy L, Flechon A, Beuzeboc P, Gravis G, Laguerre B, Theodore C, Culine S, Filleron T, Chevreau C. Intermediate analysis of a phase II trial assessing gemcitabine and cisplatin in locoregional or metastatic penile squamous cell carcinoma. BJU Int. 2016 Mar;117(3):444-9. doi: 10.1111/bju.13054. Epub 2015 Apr 27. PMID 25601543