NCT00578071

Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Brian Czito · Academic / Other
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cancer of the Esophagus

Interventions

Type	Name	Description
DRUG	Panitumumab	Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation.
DRUG	Capecitabine	Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation
DRUG	Oxaliplatin	Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation
RADIATION	Radiation Therapy (RT)	Daily for 6 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-07-01
• Completion: 2012-06-01
• First posted: 2007-12-20
• Last updated: 2015-07-02
• Results posted: 2012-08-07

Locations

1 site across 1 country: United States