NCT02154399

EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer

Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen, hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.

Detailed description

PRIMARY OBJECTIVES: I. Assess the frequency and degree of hypoxia as measured by EF5 binding in patients with non-small cell lung cancer. II. Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers of hypoxia in patients with non-small cell lung cancer. III. Correlate hypoxia as measured by EF5 binding with tissue markers of hypoxia in patients with non-small cell lung cancer. IV. Correlate hypoxia as measured by EF5 binding with tumor angiogenesis in patients with non-small cell lung cancer. V. Correlated hypoxia as measured by EF5 binding with apoptosis in patients with non-small cell lung cancer. VI. Measure and characterize tumor perfusion in relationship to hypoxia in patients with non-small cell lung cancer. VII. Correlate tumor perfusion to microvessel density in tumor samples in patients with non-small cell lung cancer. VIII. Determine the longevity of EF5 adducts in human lung tumors. OUTLINE: Patients receive EF5 intravenously (IV) over 1-2.5 hours. Beginning 24-55 hours later, patients undergo tumor hypoxia measurement using a polarographic needle electrode and intraoperative tumor measurement before undergoing surgical biopsy or resection. After completion of study treatment, patients are followed up for 4-6 weeks.

Conditions

• Stage IA Non-Small Cell Lung Carcinoma
• Stage IB Non-Small Cell Lung Carcinoma
• Stage IIA Non-Small Cell Lung Carcinoma
• Stage IIB Non-Small Cell Lung Carcinoma
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	EF5	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery/thoracotomy
OTHER	Tissue Oxygen Measurement	Undergo tumor hypoxia measurement

Timeline

• Start date: 2002-05-01
• Primary completion: 2007-09-01
• Completion: 2014-04-01
• First posted: 2014-06-03
• Last updated: 2015-04-13

Locations

2 sites across 1 country: United States