EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Platelets > 100,000/mm^3
- Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 mL/min/m^2 (EF5 is primarily excreted via the kidney)
- White blood cell (WBC) > 2000/mm^3
- ...
- Platelets > 100,000/mm^3
- Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 mL/min/m^2 (EF5 is primarily excreted via the kidney)
- White blood cell (WBC) > 2000/mm^3
- Bilirubin within normal limits
- Performance status 0-2
- Known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (NSCLC) must be estimated by their physician to have at least 75% probability of having NSCLC; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a Bayesian model
- Clinical or pathologic stage I to III; patients in whom pre-surgical staging has not definitively establish stage IV disease are eligible
- Tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (CT) scan and must be included in the planned surgical biopsy or resection
- Patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure
Exclusion Criteria
- Allergy to IV contrast dye
- Pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with EF5
- History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
- Allergy to IV contrast dye
- Pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with EF5
- History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
Summary
- 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
- Stage IIIB Non-Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 hypoxi...
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.
Inclusion Criteria
- Platelets > 100,000/mm^3
- Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 mL/min/m^2 (EF5 is primarily excreted via the kidney)
- White blood cell (WBC) > 2000/mm^3
- ...
- Platelets > 100,000/mm^3
- Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 mL/min/m^2 (EF5 is primarily excreted via the kidney)
- White blood cell (WBC) > 2000/mm^3
- Bilirubin within normal limits
- Performance status 0-2
- Known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (NSCLC) must be estimated by their physician to have at least 75% probability of having NSCLC; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a Bayesian model
- Clinical or pathologic stage I to III; patients in whom pre-surgical staging has not definitively establish stage IV disease are eligible
- Tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (CT) scan and must be included in the planned surgical biopsy or resection
- Patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure
Exclusion Criteria
- Allergy to IV contrast dye
- Pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with EF5
- History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
- Allergy to IV contrast dye
- Pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with EF5
- History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
Tracking Information
- NCT #
- NCT02154399
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael Kelley Duke University
- Michael Kelley Duke University