At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Panitumumab, Capecitabine, and 2 other interventions for Cancer of the Esophagus. Completed, enrolled 29 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.
Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation
Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation
Daily for 6 weeks