A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.
Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.
详细描述
Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.
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
- •Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.
- •age above 18 years
- •WHO performance status 0-2
- •Life expectancy > 3 months
- •Previous treatment with one platinum and taxane containing regimen.
- •Platinum and taxane sensitive relapse
- •At least one evaluable/measurable lesion.
- •Adequate hematologic, renal and liver function
- •Consent form signed and dated before inclusion
排除标准
- •Prior treatment with more than one line of chemotherapy
- •Concurrent severe and/or uncontrolled co-morbid medical condition.
- •History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock
- •Pregnant or lactating women (or potentially fertile women not using adequate contraception)
- •Peripheral neuropathy > Grade 2
- •History of allergy to drugs containing the excipient TWEEN 80®.
- •Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy
- •Clinical evidence of brain metastases
研究组 & 干预措施
Carboplatin and docetaxel
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
干预措施: Carboplatin (Drug)
Carboplatin and docetaxel
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Safety
时间窗: Up to 30 days after last chemotherapy course
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included.
次要结局
- Response rate(Up to 30 dayes after last chemotherapy course)
- Progression free survival(Up to 3 year)