Cancer of the Esophagus Clinical Trial
Official title:
A Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin Chemotherapy With External Beam Radiation Therapy for the Treatment of Resectable, Locally Advanced/Unresectable or Metastatic Esophageal Cancer
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal junction. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.
This study has a phase I/II design. For this study the administration of panitumumab is
considered investigational.
Pretreatment: Part of regular cancer care and disease staging includes Chest/Abdomen CT
Scan, upper endoscopic ultrasound, PET scan, J-Tube Placement (if clinically indicated),
bronchoscopy (per clinician judgment), ECG, and baseline laboratory studies.
During Treatment Weeks 1-5.5 of Radiation Therapy(RT)/Chemotherapy:
- RT (180 cGy/fx, Mon-Fri) days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38.
- Panitumumab (per dose level) days 1, 15, 29.
- Oxaliplatin (per dose level) days 1, 8, 15, 22, 29, 36.
- Capecitabine (per dose level M-F) 1-5, 8-12, 15-19, 22-26, 29-33, 36-38.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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