Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer (POXX)
|Cancer of the Esophagus||Drug: Panitumumab Drug: Capecitabine Drug: Oxaliplatin Radiation: Radiation Therapy (RT)||Phase 1 Phase 2|
|Study Design:||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 ]
- 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. [ Time Frame: One year ]Number of patients alive one year after completing study protocol treatment.
- Pathological Complete Response Rates Associated With This Regimen. [ Time Frame: 90 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578071
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Brian Czito, MD||Duke University|