A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 13
- 主要终点
- Non-progression rate as measured by RECIST v2.0 at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the efficacy markers of docetaxel and PI-88 in these patients.
- Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy.
- Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PI-88+docetaxel
treated with docetaxel and PI-88
干预措施: PI-88 (Drug)
PI-88+docetaxel
treated with docetaxel and PI-88
干预措施: docetaxel (Drug)
docetaxel
treated with docetaxel alone
干预措施: docetaxel (Drug)
结局指标
主要结局
Non-progression rate as measured by RECIST v2.0 at 6 months
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
次要结局
- Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
- Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
- Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
- Overall survival as measured by RECIST v2.0 at death