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

Last updated: April 10, 2015
Sponsor: National Cancer Institute (NCI)
Overall Status: Completed

Phase

2

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT02154399
NCI-2014-01169
R21CA091565
NCI-2014-01169
2310
P30CA014236
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Known or suspected non-small cell lung cancer; patients without histologically orcytologically documented non-small cell lung cancer (NSCLC) must be estimated by theirphysician to have at least 75% probability of having NSCLC; the probability ofmalignancy will be predicted on the basis of known probabilities of individualclinical characteristics using a Bayesian model

  • Clinical or pathologic stage I to III; patients in whom pre-surgical staging has notdefinitively 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 theclinical 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 60mL/min/m^2 (EF5 is primarily excreted via the kidney)

  • White blood cell (WBC) > 2000/mm^3

  • Platelets > 100,000/mm^3

Exclusion

Exclusion Criteria:

  • Pregnancy or breast feeding; a negative serum pregnancy test is required of any womanof childbearing potential prior to enrollment; pregnant women are excluded from thisstudy; 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 CancerInstitute (NCI) Common Terminology Criteria (CTC)

Study Design

Total Participants: 28
Study Start date:
May 01, 2002
Estimated Completion Date:
April 30, 2014

Study 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.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Durham Veterans Affairs Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

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