Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Duke University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue.
PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES: * 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 these patients. * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion
Secondary Outcomes
- Correlation of hypoxia with serum/plasma markers of hypoxia, tissue markers of hypoxia, tumor angiogenesis, apoptosis, tumor perfusion, and microvessel density at 24 to 48 hrs. after study drug infusion
- Longevity of EF5 adducts as measured by EF5 binding