Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
- Assess the frequency and degree of hypoxia as measured by etanidazole derivative EF5
binding in patients with stage I, II, or III non-small cell lung cancer.
- Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers and
tissue markers of hypoxia in these patients.
- Correlate hypoxia as measured by EF5 binding with tumor angiogenesis and apoptosis in
- Correlate tumor perfusion with hypoxia in these patients.
- Correlate tumor perfusion with microvessel density in tumor samples in these patients.
- Determine the longevity of EF5 adducts in human lung tumors.
OUTLINE: Patients are stratified according to disease stage (stage I or II vs stage III vs
no stage I-III determined after pathologic staging).
Within 24-48 hours prior to the planned surgical procedure, patients receive etanidazole
derivative EF5 IV over 1-2.5 hours. Tumor hypoxia is then measured using an intraoperative
Eppendorf needle electrode during surgical biopsy or resection. Tumor specimens are tested
for EF5 binding using immunohistochemistry and flow cytometry.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 40-60 patients (20 with stage I/II disease, 20 with stage III
disease, and 20 without stage I-III disease) will be accrued for this study.
Primary Purpose: Diagnostic
Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion
Michael J. Kelley, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Veterans Affairs Medical Center - Durham||Durham, North Carolina 27705|