NCT00226746撤回2 期
A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer
New York Presbyterian Brooklyn Methodist Hospital1 个研究点 分布在 1 个国家开始时间: 2003年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- One-year overall survival rate
研究概览
简要总结
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.
详细描述
Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.
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
- •Pathologically confirmed adenocarcinoma of the pancreas.
- •Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
- •Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible.
- •Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
- •All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum).
- •All patients must have radiographically assessable disease.
- •Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Required entry laboratory parameters: granulocytes >/= 1,800/µl, platelet count >/= 100,000/µl, bilirubin < 2.0 mg/dL, alanine aminotransferase (ALT) < 3 x upper limit of normal, and creatinine < 3.0 mg/dL.
- •Signed study-specific consent form prior to study entry.
排除标准
- •Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
- •Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
- •Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- •Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
研究组 & 干预措施
Paclitaxel and Gemcitabine
Experimental
Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.
Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
干预措施: Paclitaxel and gemcitabine (Drug)
结局指标
主要结局
One-year overall survival rate
时间窗: Up to June 2010
Follow up for survival will be done to know this outcome
次要结局
- Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary(year 2010)
- Occurrence of pathological response or shrinkage of the tumor (becomes resectable)(year 2010)
研究者
Hani Ashamalla, MD
MD
New York Presbyterian Brooklyn Methodist Hospital
研究点 (1)
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