EUCTR2006-001724-40-IT进行中（未招募）不适用
Phase II study with capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer - MITO-6
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE0 个研究点目标入组 32 人开始时间: 2006年6月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Cytologic or histologic diagnosis of relapsed ovarian cancer Refractory or resistant to platinum salts disease Age 75 years At least one measurable lesion 20 mm with conventional techniques or 10 mm with spiral CT scan Life expectancy of at least 3 months Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix . Performance Status ECOG 3 Previous chemotherapy treatment with capecitabine More than 3 lines of chemotherapy Heart disease heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia Leukocytes 4000/mm3, platelets 100000/mm3 Modifications of renal function Creatininaemia 1.25 times the upper normal limit or liver function SGOT or SGPT 1.25 times the upper normal limit Present or suspected haemorrhagic syndromes Uncooperative and/or unreliable patients Patients inability to access the centre
研究者
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