Clinical trial NCT02154399: EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer
Official title: Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2014-06-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Frequency and degree of hypoxia using a polarographic needle electrode
timeFrame: 55 hours post-EF5 infusion
measure: Serum/plasma markers of hypoxia
timeFrame: 55 hours post-EF5 infusion
measure: Tissue markers of hypoxia
timeFrame: 55 hours post-EF5 infusion
measure: Tumor perfusion using dynamic positron emission tomography
timeFrame: 10 days prior to surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Veterans Affairs Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Kelley
role: PRINCIPAL_INVESTIGATOR
References: