NCT00439608已完成2 期
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reponse Rate at Time of Surgery by Tissue
研究概览
简要总结
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
详细描述
The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.
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
- •Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
- •Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy.
- •There must be no evidence of distant organ metastases.
- •No prior radiation for gastric or esophageal cancer.
- •Patients must be > 18 years of age, and nonpregnant
- •Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN.
- •ECOG performance status 0-
- •Patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy.
- •Female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible.
- •All patients must sign informed consent
排除标准
- •Any of the following criteria will make the patient ineligible to participate in this study:
- •Acute hepatitis or AIDS.
- •Active or uncontrolled infection.
- •Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- •Prior therapy which specifically and directly targets the EGFR pathway.
- •Prior severe infusion reaction to a monoclonal antibody.
- •Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
研究组 & 干预措施
Treatment
Experimental
Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
干预措施: Cetuximab,Paclitaxel, Carboplatin (Drug)
结局指标
主要结局
Reponse Rate at Time of Surgery by Tissue
时间窗: within 30 days of last treatment
pathologic complete response rate at surgery
次要结局
- Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach.(baseline, then during treatment, about 5 weeks through 30 days post treatment.)
研究者
howard safran
Principal Investigator
Brown University
研究点 (1)
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