Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Efficacy of combining Celecoxib with Docetaxel
研究概览
简要总结
RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.
详细描述
OBJECTIVES:
- Determine the efficacy and feasibility of celecoxib combined with docetaxel in patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.
- Determine the response rate of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral celecoxib twice daily (beginning on day -7 of the first course) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses after CR. Patients who achieve stable disease (SD) or a partial response (PR) receive a minimum of 2 additional courses after SD or PR. At the discretion of the treating physician, patients then receive maintenance therapy comprising celecoxib only.
Patients who discontinue therapy for disease progression or unacceptable toxicity are followed for at least 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Celecoxib & Docetaxel
Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
干预措施: Celecoxib (Drug)
Celecoxib & Docetaxel
Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment.
Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
干预措施: Docetaxel (Drug)
结局指标
主要结局
Efficacy of combining Celecoxib with Docetaxel
时间窗: Weeks 1 , 2 and 3
Blood levels of VEGF \& PGE2
次要结局
- Response rate of Celecoxib and Docetaxel(Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.)
- Toxicity of Celecoxib and Docetaxel(Every week)
- Expression of cyclooxygenase-2 (COX-2) in tumors(Pre-study)
- Changes in plasma levels of prostaglandin E2 (PGE2) & vascular endthelial growth factor (VEGF)(Pre-study; Weeks 1 , 2 and 3)
- Vascular changes induced in the tumor by celecoxib(Weeks 1, 3 & 6)