NCT00193583已完成1 期
A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.
详细描述
Upon determination of eligibility, patients will be receive:
- Topotecan + Carboplatin
In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Adult patients at least 18 years old
- •Advanced solid tumors refractory to conventional therapy
- •ECOG performance status must be 0 or 1
- •Patients may have received no more than 3 prior chemotherapy regimens
- •Adequate bone marrow, liver and kidney function
- •Able to understand the nature of the study and give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Active concurrent infections or serious underlying medical conditions
- •Known HIV positivity
- •Female patients who are pregnant or lactating
- •Received both topotecan and carboplatin
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Maximum tolerated dose
次要结局
- Dose limiting toxicity
- All over response
研究者
研究点 (2)
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