Patient case: 50-year-old male with non-small cell lung cancer; genetic feature: EGFR (T790M)

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

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.

Eligibility: 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)

Relevance to patient case: not relevant