Conditions: Cancer of the Esophagus
Keywords: esophageal cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 29
Healthy volunteers: no

Brief 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.

Arms:
arm 1: panitumumab, oxaliplatin, capecitabine and EBRT

Interventions: intervention 1: Panitumumab intervention 2: Capecitabine intervention 3: Oxaliplatin intervention 4: Radiation Therapy (RT)
Intervention descriptions: intervention 1: Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation. intervention 2: Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation intervention 3: Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation intervention 4: Daily for 6 weeks

Protocol document: