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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• 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

• Performance status 0-2

• Bilirubin within normal limits

• 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

Exclusion Criteria:

• 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

• Allergy to IV contrast dye

• History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)