A Pilot Study of the Biologic Efficacy and Safety of the Addition of Celecoxib to a Program of Induction Chemotherapy and Neo-Adjuvant Chemo-Radiotherapy for the Treatment of Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Rates of cellular apoptosis and proliferation
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy and radiation therapy together with celecoxib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan and cisplatin together with radiation therapy with or without celecoxib works in treating patients with stage II, stage III, or stage IV esophageal cancer.
详细描述
OBJECTIVES:
Primary
- To measure the rates of cellular apoptosis and proliferation at baseline and during chemoradiotherapy with and without celecoxib using biopsy samples from patients with stage II, III, or IV esophageal cancer.
- To determine if an acceptable rate of pathologic complete remission can be achieved in a subset of patients with potentially resectable esophageal cancer.
Secondary
- To assess the safety of the addition of daily celecoxib to chemoradiotherapy.
- To estimate the median overall survival in a subset of patients with resectable disease.
- To quantitate expression of cyclooxygenase (COX)-2 and formation of prostaglandin E2 (PGE2) in patients with esophageal cancer.
- To assess the ability of celecoxib to decrease formation of PGE2 in tumor tissue by measuring pre- and post-treatment tumor concentrations of PGE2.
- To quantitate downstream effects of inhibition of COX-2 function in the setting of treatment with chemotherapy.
- To measure the radiographic response rate in patients with unresectable esophageal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（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
Cohort 1
Induction chemotherapy and chemoradiation without celecoxib
干预措施: CPT- 11 (Drug)
Cohort 1
Induction chemotherapy and chemoradiation without celecoxib
干预措施: Cisplatin (Drug)
Cohort 1
Induction chemotherapy and chemoradiation without celecoxib
干预措施: Radiation (Radiation)
Cohort 1
Induction chemotherapy and chemoradiation without celecoxib
干预措施: Surgery (Procedure)
Cohort 2
Induction chemotherapy and chemoradiation with celecoxib
干预措施: CPT- 11 (Drug)
Cohort 2
Induction chemotherapy and chemoradiation with celecoxib
干预措施: Cisplatin (Drug)
Cohort 2
Induction chemotherapy and chemoradiation with celecoxib
干预措施: Celecoxib (Drug)
Cohort 2
Induction chemotherapy and chemoradiation with celecoxib
干预措施: Radiation (Radiation)
Cohort 2
Induction chemotherapy and chemoradiation with celecoxib
干预措施: Surgery (Procedure)
结局指标
主要结局
Rates of cellular apoptosis and proliferation
时间窗: 5 weeks
Measure the rates of cellular apoptotis and proliferation in esophageal cancers from biopsy samples pre-study and during chemoradiation with and without celecoxib therapy
Rate of pathologic complete remission in patients with resectable disease
时间窗: 4 years
To determine if an acceptable rate of pathologic complete remissions can be achieved in a cohort of patients with potentially resectable esophageal carcinoma
次要结局
- Number of subjects experiencing adverse events(30 days post radiation)
- Median overall survival of patients with resectable disease(4 years)
- Formation of prostaglandin E2 (PGE2) in tumor tissue(12 weeks)
- Downstream effects of inhibition of cyclooxygenase 2 function(12 weeks)
- Response Rate(4 years)