NCT01705158已完成1 期
Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum
ARCAGY/ GINECO GROUP42 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 42
- 主要终点
- Determine the control disease rate in 1 year
研究概览
简要总结
The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.
详细描述
In front of a shortage of Caelyx, the implementation of an alternative treatment must be considered to treat patients with ovarian cancer in relapse, sensitive to platin: associate the carboplatin with another drug of the family of the doxorubicin: liposomal doxorubicin (Myocet®).
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
- •First or second relapse of a carcinoma of the ovary, the fallopian tubes or the peritoneal tissue histological proved.
- •Interval without progress > 6 months after the last administration of a salt of platinum(deck).
- •Measurable Disease (according to the criteria RECIST 1.1) or an assessable disease according to CA-125 (according to the criteria of the GCIG).
- •Satisfactory biological Balance sheet(Assessment), according to the following criteria:
- •Neutrophiles > 1,5x 109/L, Plaques > 100 x 109/L, Haemoglobin > 9,0 g/dL.
- •Bilirubine < 1.5 x LSN (Normal Superior Limit), transaminases and alkaline phosphatase <
- •Creatinin clearance > 50 mL/min calculated according to the formula of Cockroft-Gault or MDRD.
- •Performance status <
- •Life expectancy of at least 12 weeks.
- •Age > 18 years.
- •Capacity to follow the protocol.
- •Consent signed before any procedure of inclusion.
- •Membership in a national insurance scheme.
排除标准
- •Tumor of mild histology or borderline, or malignant not epithelial tumor of the ovary, the fallopian tubes or the peritoneal tissue(eg. tumor of germ cells, tumor of the sexual cords and the stroma).
- •History of abdominal or pelvic radiotherapy.
- •Patient having received more than 2 lines of chemotherapy.
- •Patient in 3rd relapse or more.
- •History of another malignant tumor during the last 5 years, with the exception of a carcinoma in situ by the neck of the womb or by a squamous-cell carcinoma of the skin treated in a adequate way or any solid tumor considered in forgiveness completes without relapse for at least 5 years.
- •Patients having a stubborn illness in the platinum, (eg. progress during the last chemotherapy or in 6 months following the last administration of platinum).
- •Occlusive or sub-occlusive disease or presence of symptomatic intellectual metastases.
- •Heart disorder dissuading the use of an anthracycline.
- •Left venticular ejection fraction (LVEF) defined by MUGA/ECHO < 50%.
- •Wait presenting a severe infection.
- •Woman old enough to procreate not using adequate contraceptive method.
- •Concomitant disease not allowing a surgery and/or a chemotherapy.
- •Pathology severe or concomitant not compatible with the taking of the study treatment or the participation of the patient in the study.
研究组 & 干预措施
carboplatin and liposomal doxorubicin
Experimental
carboplatin and liposomal doxorubicin in ovarian cancer in realapse
干预措施: carboplatin and liposomal doxorubicin (Drug)
结局指标
主要结局
Determine the control disease rate in 1 year
时间窗: 12 months
To determine the proportion of not progressive patients in 1 year (rate of control of the disease or the rate of not progress in 12 months)
次要结局
- To estimate the rate of objective answer (CR/PR)(2,5 years)
研究者
研究点 (42)
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