NCT00429559已完成1 期
Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
Hellenic Oncology Research Group6 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2006年6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
- 31
- 试验地点
- 6
- 主要终点
- Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.
研究概览
简要总结
Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed ovarian adenocarcinoma
- •Patients had to have received a front-line, platinum- based chemotherapy regimen
- •Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy
- •Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125
- •A >= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
- •Age > 18 years old
- •Performance status (WHO) 0-2
- •Life expectancy of at least three months
- •Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
- •Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl)
- •Informed consent
排除标准
- •Pregnant or nursing
- •Psychiatric illness or social situation that would preclude study compliance
- •Other concurrent uncontrolled illness
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
研究组 & 干预措施
A
Experimental
干预措施: Hycamptin (Drug)
A
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.
时间窗: 1year
次要结局
- Toxicity profile(1 year)
研究者
研究点 (6)
Loading locations...
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