Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer (POXX)
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.
Cancer of the Esophagus
Radiation: Radiation Therapy (RT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Panitumumab Maximum Tolerated Dose in Milligrams (mg) [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
- Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Within 30 days of the last day of radiation ] [ Designated as safety issue: Yes ]
- Describe the 2 Year Overall Survival Rates for the Patients Studied on This Protocol. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]Number of patients alive two years after the date of diagnosis.
- Pathological Complete Response Rates Associated With This Regimen. [ Time Frame: 90 days ] [ Designated as safety issue: No ]Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.
|Study Start Date:||December 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
panitumumab, oxaliplatin, capecitabine and EBRT
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
Other Name: XelodaDrug: Oxaliplatin
Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiationRadiation: Radiation Therapy (RT)
Daily for 6 weeks
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.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Brian Czito, MD||Duke University|