NCT00518193终止2 期
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
ARCAGY/ GINECO GROUP8 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- responses rate regarding the RECIST criteria.
研究概览
简要总结
The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .
News thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.
Cetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.
Cisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.
Many clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old.
- •Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved
- •Patientes in a late stage or with progresive desease.
- •One mesurable lesion in irradiated zone.
- •Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.
- •Index status of ECOG (" Eastern Cooperative Oncology Group ")less than
- •Good biologicals and hematologicals fonctions:
- •Neutrophiles noless than 1,5.109/L.
- •Platelets nolss than 100.109/L.
- •Total bilirubin no more than 1,5 time the normal superior range.
- •Transaminases no mote than 3 x Time NSR
- •Creatinine clairance Cockroft) more than 50 mL/min .
- •Inform consent signed.
排除标准
- •Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.
- •Other cancer in the last 5 years exept treated BCC.
- •Dermatologic desease.
- •Crohn desease or Hemorragic rectal-Colitis.
- •Neuropathy.
- •Psychologic disorder.
- •Social troubles.
- •Pregnant women.
结局指标
主要结局
responses rate regarding the RECIST criteria.
时间窗: up to progression
次要结局
- Quality of life, free interval, safety.(up to progression)
研究者
研究点 (8)
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