Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer (POXX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00578071|
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : August 7, 2012
Last Update Posted : July 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Esophagus||Drug: Panitumumab Drug: Capecitabine Drug: Oxaliplatin Radiation: Radiation Therapy (RT)||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2007|
|Primary Completion Date :||July 2011|
|Study Completion Date :||June 2012|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578071
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Brian Czito, MD||Duke University|