NCT00210041已完成2 期
Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- To evaluate objective response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate objective response rate
时间窗: until desease progression
次要结局
- global survival(untill death)
- To evaluate tolerance of the association,(during all participation of the subject)
- time to progression,(untill progression)
研究者
研究点 (11)
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