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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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
Duke University Medical Center
Durham, North Carolina, United States
Panitumumab Maximum Tolerated Dose in Milligrams (mg)
Time frame: 60 days
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Within 30 days of the last day of radiation
Overall Survival Rates for the Patients Studied on This Protocol.
Number of patients alive one year after completing study protocol treatment.
Time frame: One year
Pathological Complete Response Rates Associated With This Regimen.
Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.
Time frame: 90 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.