This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
The study treatment for this protocol is * Loading dose of Cetuximab 400 mg/m2 * Weekly Cetuximab 250 mg/m2 * Bi-weekly Gemcitabine 50 mg/m2 * Daily Radiation for 28 fractions * CT scan four weeks after completion of treatment * Evaluation by surgeon for resectability
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
Daily radiotherapy for 28 days
Objective Response of Tumor by RECIST 1.0 Criteria
Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
Time frame: one month post-therapy
Number of Participants Assessed for Adverse Events
Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0
Time frame: Participants were followed during treatment and for 30 days after completion of treatment
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).
Time frame: 1 month after completion of treatment
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.
Time frame: One month post-therapy
Disease-Free Survival After Therapy
Time to disease progression after therapy.
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Time frame: Five years post treatment
Overall Length of Survival After Therapy
Length of survival after therapy in all participants enrolled.
Time frame: Five years post treatment
Pattern of Failure After Therapy
Local recurrence, distant recurrence, or both.
Time frame: Five years post treatment