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

Stage IIIB Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154399
• Other study ID #: NCI-2014-01169
• Secondary ID: NCI-2014-0116923
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2014
• Last updated: April 10, 2015
• Start date: May 2002
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2014
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham Veterans Affairs Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and degree of hypoxia using a polarographic needle electrode		55 hours post-EF5 infusion	No
Primary	Serum/plasma markers of hypoxia	Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with serum markers of hypoxia (vascular endothelial growth factor [VEGF], D-Dimer, plasminogen activator inhibitor type 1 [PAI-1]).	55 hours post-EF5 infusion	No
Primary	Tissue markers of hypoxia	Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with tissue markers of hypoxia (hypoxia inducible factor 1 [HIF-1] alpha, involucrin).	55 hours post-EF5 infusion	No
Primary	Tumor perfusion using dynamic positron emission tomography	Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with tumor perfusion.	10 days prior to surgery	No