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

NCT02154399 | Completed Phase 2 DMC

• 4 other identifiers: NCI-2014-011692310P30CA014236R21CA091565
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• Frequency and degree of hypoxia using a polarographic needle electrode

  55 hours post-EF5 infusion

• 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

• 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

• 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

Study Arms (1)

Treatment (EF5)

EXPERIMENTAL

Patients receive EF5 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.

Drug: EF5; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery; Other: Tissue Oxygen Measurement

Interventions

EF5 DRUG

Given IV

Also known as: EF-5

Treatment (EF5)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (EF5)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery/thoracotomy

Treatment (EF5)

Tissue Oxygen Measurement OTHER

Undergo tumor hypoxia measurement

Treatment (EF5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Durham Veterans Affairs Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Kelley

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: May 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: April 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2014-06

Locations

US (2)