This study proposes a single-arm, phase II study of irinotecan with panitumumab as
second-line therapy for patients with advanced esophageal adenocarcinoma. Efficacy will be
assessed by response rate, with an exploratory outcome endpoint of time to progression (as
panitumumab may result in prolonged stable disease). In addition to the usual safety
assessments, molecular correlates will be carried out in order to search for pharmacodynamic
and pharmacogenomic features that may correlate with response. Measures of host/patient
immune function will be assessed by evaluating the relationship between Fc receptor
polymorphisms and response in patients treated with panitumumab. Measures of EGFR protein and
phosphoprotein expression by immunohistochemical- (IHC-) staining, K-ras mutation status1 and
reverse-phase protein arrays (RPPA) and EGFR gene amplification by fluorescence in situ
hybridization (FISH) will be assessed as exploratory correlates.