NCT00231075已完成2 期
National, Phase II Study Designed to Evaluate the Safety and Efficacy of Paraplatin in Combination With Taxol in Patients of 70 Years and Older With Ovary Cancer F.I.G.O. Stages III and IV. FAG-2
ARCAGY/ GINECO GROUP2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2001年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
研究概览
简要总结
Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.
详细描述
The Main objective of this study is to evaluate the faisibility of chemotherapy with Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV and to determine principal predictive factors of this feasibility.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
- •Patient aged > 70 years
- •Neutrophil polynuclears > 1500/mm3 and Platelets > 100 000/mm3
- •No clinical icterus
- •Life expectancy of at least 3 months
排除标准
- •Previous diagnosis of malignancy
- •Previous chemotherapy treatment
- •Previous radiotherapy
- •Hypersensitivity to products containing Cremophore EL
- •Hepatic values: bilirubine > 2*LSN, SGOT-SGPT > 2*LSN and/or Alkalin phosphatase > 3*LSN
- •Myocardiopathy with arrhythmia
结局指标
主要结局
Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)
次要结局
- Toxicity assessment
- Overall survival
- Progression-free survival
- Rate of response
- Quality of life
研究者
研究点 (2)
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