At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed locally recurrent or metastatic adenocarcinoma of the esophagus incurable with standard therapy
- ✓Measurable disease outside prior radiation port or biopsy-proven recurrent disease within port
- ✓One prior chemotherapy regimen for metastatic disease (excluding prior irinotecan or panitumumab)
- ✓Age >18 years
- ✕CNS metastases unless irradiated and stable
- ✕Prior anti-EGFR antibody therapy (e.g., cetuximab) or EGFR small-molecule inhibitors (e.g., gefitinib, erlotinib, lapatinib)
- ✕Pre-existing peripheral neuropathy >grade 1
- ✕History of allergic reactions to compounds similar to panitumumab or irinotecan
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Irinotecan and Panitumumab as Second-Line Therapy for Patients With Advanced Esophageal Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating Panitumumab and Irinotecan for Esophageal Cancer. Completed, enrolled 24 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
9mg/kg IV Day 1 Cycle = 21 days
125mg/m2 IV Day 1 and Day 8