NCT00061308已完成2 期
An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 20
- 主要终点
- response rate
研究概览
简要总结
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.
- •At least 4 weeks since last surgery or radiation therapy.
- •Must have had a treatment-free interval of greater than 6 months following response to platinum.
- •ECOG performance status of 0,1, or 2.
排除标准
- •Women of child-bearing potential that do not practice adequate contraception.
- •Pregnant or lactating.
- •Received more than one primary chemotherapy regimen.
- •Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.
- •Active uncontrolled infection requiring antibiotics.
- •Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study.
- •Received radiation to more than 10% of bone.
- •Prior treatment with topotecan or gemcitabine.
- •Hypersensitivity to camptothecin or nucleoside analogues.
- •Use of an investigational agent within 30 days.
结局指标
主要结局
response rate
次要结局
- response duration time to response time to progression survival safety
研究者
研究点 (20)
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