NCT00886717Unknown1 期
Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 74
- 试验地点
- 8
- 主要终点
- Maximum tolerated dose and recommended phase II dose (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I)
- Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)
Secondary
- Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)
- Evaluate the safety profiles of this regimen in these patients. (Phase I)
- Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Determine the overall response in patients treated with this regimen. (Phase II)
- Evaluate the safety and toxicity of this regimen in these patients. (Phase II)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose and recommended phase II dose (Phase I)
Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)
次要结局
- Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I)
- Overall response (Phase II)
- Objective response rate as measured by RECIST criteria (Phase II)
- Overall survival (Phase II)
- Safety profiles (Phase I)
- Safety and toxicity (Phase II)
研究者
研究点 (8)
Loading locations...
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