A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
研究概览
简要总结
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
详细描述
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Locally advanced carcinoma of the pancreas
- •Arterial invasion or encasement
- •Invasion/encasement of the portomesenteric veins
- •Patients who have been previously denied operation
- •Obstructive jaundice must be drained with a polyethylene biliary stent or surgical bypass prior to beginning treatment.
- •White blood cell count > 3500 per ml and platelet count > 100,000 per ml
- •Serum creatinine ≤ 1.5 mg/dl
- •Bilirubin ≤ 1.5
- •ECOG performance status < 2
排除标准
- •Prior chemotherapy, radiotherapy, or investigational agents for pancreatic cancer
- •Evidence of distant metastasis or malignant lymphadenopathy
- •Concurrent malignancies
- •History of allergic reactions to celecoxib or to sulfa drugs
- •No non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, magnesium or aluminum containing antacids, fluconazole or lithium may be administered within 5 days of study entry, during the study and for the 30 days following the completion of all study treatments.
- •Pregnant women and lactating women
- •Uncontrolled or serious intercurrent illness
- •HIV-positive patients receiving combination antiretroviral therapy
研究组 & 干预措施
1
Celecoxib, Irinotecan and Concurrent Radiotherapy
干预措施: celecoxib (Drug)
1
Celecoxib, Irinotecan and Concurrent Radiotherapy
干预措施: irinotecan (Drug)
1
Celecoxib, Irinotecan and Concurrent Radiotherapy
干预措施: concurrent radiotherapy (Procedure)
结局指标
主要结局
Determine efficacy of combination of irinotecan, celecoxib and concurrent radiotherapy on pancreatic cancer; determine highest/safest doses of these drugs
时间窗: 12 weeks
次要结局
- Tumor diminishment for safe excision(75 days)