NCT00319735已完成2 期
A Pilot Study With Cetuximab and Radiation Therapy for Patients With Surgically Resectable Esophageal and GE Junction Carcinomas: Hoosier Oncology Group Study (GI05-92)
Nasser Hanna, M.D.14 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2006年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 14
- 主要终点
- Complete Pathologic Response (pCR)
研究概览
简要总结
The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These interactions may represent the principle effects that contribute to the synergy between EGFR and radiation.
This trial will investigate the feasibility and activity of this combination in patients with surgically resectable disease.
详细描述
OUTLINE: This is a multi-center study.
- Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose)
- Cetuximab 250 mg/m2 IV over 60 minutes, day -7.
- Cetuximab 250 mg/m2 IV over 60 minutes, days 1, 8, 15, 22, 29 and 36.
- External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks.
- Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy.
- For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of cetuximab, and at the time of surgery for pathology submission.
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
- •Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction.
- •Clinical stage IIA, IIB or III without metastatic disease
- •Patients must have documented EGFR status or have tumor tissue available for assessment of EGFR status by IHC
- •Patients must be surgical candidates as determined by surgical consult.
- •Patients must agree to surgery.
- •ECOG performance status 0 or 2
- •Absolute neutrophil count (ANC) > 1,000 mm3
- •Platelet count > 75,000 mm3· Hemoglobin > 10g/dL
- •Bilirubin < 2.5 X upper limit of normal
- •AST (SGOT) or ALT (SGPT) < 5.0 ´ upper limit of normal
- •Creatinine < 2.0 X upper limit of normal
排除标准
- •No history of or current brain metastasis.
- •No 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.
- •No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of interstitial pneumonitis or pulmonary fibrosis on imaging.
- •No concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
- •No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction
- •No prior therapy that specifically and directly targets the EGFR pathway (such as kinase inhibitors and antibodies directed against the HER family receptors).
- •No prior severe infusion reaction to a monoclonal antibody.
- •No major surgery within 28 days prior to being registered for protocol therapy.
- •No clinically significant infections as judged by the treating investigator.
- •No acute hepatitis or known HIV.
- •No other active malignancies.
- •Negative pregnancy test.
- •No female patients currently breastfeeding.
结局指标
主要结局
Complete Pathologic Response (pCR)
时间窗: 36 months
To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas. Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.
次要结局
- Time to Relief of Dysphagia(36 months)
- Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.(Up to 36 months)
- Evaluate Toxicity(36 months)
- Perform Exploratory Molecular Correlates.(36 months)
- Complete and Partial Response Rate for Patients by Disease Stage: IIA(36 months)
- Complete and Partial Response Rate for Patients by Disease Stage: IIB(36 months)
- Complete and Partial Response Rate for Patients by Disease Stage: III(36 months)
- Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma(36 months)
- Complete and Partial Response Rate for Patients by Histology: Squamous Cell(36 months)
研究者
Nasser Hanna, M.D.
Sponsor-Investigator
Hoosier Cancer Research Network
研究点 (14)
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