NCT00045591终止2 期
Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 74
- 主要终点
- Progression free survival
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
详细描述
OBJECTIVES:
Primary
- Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib.
Secondary
- Compare the side effects of the 2 dose levels of this drug in these patients.
- Compare the overall survival of patients treated with the 2 dose levels of this drug.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
研究组 & 干预措施
Celecoxib 100 mg
Experimental
干预措施: Celecoxib (Drug)
Celecoxib 400 mg
Experimental
干预措施: Celecoxib (Drug)
结局指标
主要结局
Progression free survival
时间窗: 28 months
次要结局
未报告次要终点
研究者
研究点 (74)
Loading locations...
相似试验
终止
2 期
Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the RectumColorectal CancerNCT00081224Alliance for Clinical Trials in Oncology3
已完成
2 期
Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal CancerColorectal CancerNCT00258232Barbara Ann Karmanos Cancer Institute
终止
2 期
Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung CancerLung CancerNCT00520845Vanderbilt-Ingram Cancer Center23
终止
2 期
Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RTBrain and Central Nervous System TumorsNCT00068770Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins35
已完成
1 期
Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00104767Jonsson Comprehensive Cancer Center7