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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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 chemotherapy, and at the time of surgery for pathology submission
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Community Regional Cancer Center
Indianapolis, Indiana, United States
AP&S Clinic
Terre Haute, Indiana, United States
Complete Pathologic Response (pCR)
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.
Time frame: 36 months
Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.
To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy. Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.
Time frame: Up to 36 months
Time to Relief of Dysphagia
To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab
Time frame: 36 months
Evaluate Toxicity
To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Time frame: 36 months
Perform Exploratory Molecular Correlates.
To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.
Time frame: 36 months
Complete and Partial Response Rate for Patients by Disease Stage: IIA
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Time frame: 36 months
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Siteman Cancer Center
St Louis, Missouri, United States
Texas Oncology, PA
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Complete and Partial Response Rate for Patients by Disease Stage: IIB
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Time frame: 36 months
Complete and Partial Response Rate for Patients by Disease Stage: III
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Time frame: 36 months
Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Time frame: 36 months
Complete and Partial Response Rate for Patients by Histology: Squamous Cell
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Time frame: 36 months