NCT00401674已完成2 期
Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
National Cancer Institute, Naples10 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2003年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.
详细描述
This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 70 years or greater
- •Cytologic / histologic diagnosis ovarian cancer
- •Stage of disease at diagnosis IC -IV
- •Performance status (ECOG) < 3
- •Indication for chemotherapy treatment
- •Written informed consent
排除标准
- •Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
- •Cerebral metastases
- •Neutrophils < 1000/mm3, platelets < 100000/mm3, hemoglobin < 8g/dl
- •Creatinine > o = 1.25 times the upper normal limit
- •GOT or GPT > o = 1.25 times the upper normal limit, except in case of liver metastases)
- •Patient's inability to comply with followup
研究组 & 干预措施
SINGLE ARM
Experimental
干预措施: carboplatin (Drug)
SINGLE ARM
Experimental
干预措施: paclitaxel (Drug)
结局指标
主要结局
Objective response rate
时间窗: 6 month
Toxicity
时间窗: up to 6 months
assessed weekly
次要结局
- possible predictive factors of the geriatric ADL and IADL scales(6 months)
研究者
研究点 (10)
Loading locations...
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