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EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EF5
flow cytometry
immunohistochemistry staining method
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed or suspected non-small cell lung cancer (NSCLC) If there is no histological or cytological documentation of NSCLC, must have at least a 75% probability of having NSCLC Clinical or pathological stage I-III Patients in whom pre-surgical staging has not definitively established stage IV disease are allowed Tumor mass of ≥ 1.5 cm in maximum diameter must be present on CT scan and must be included in the planned surgical biopsy or resection Must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: WBC > 2,000/mm^3 Platelet count > 100,000/mm^3 Hepatic: Bilirubin normal Renal: Creatinine normal OR Creatinine clearance ≥ 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study participation Able to hold breath for 27 seconds No allergy to IV contrast dye No history of grade III or IV peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Sites / Locations

  • Duke Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Durham

Outcomes

Primary Outcome Measures

Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion

Secondary Outcome Measures

Correlation of hypoxia with serum/plasma markers of hypoxia, tissue markers of hypoxia, tumor angiogenesis, apoptosis, tumor perfusion, and microvessel density at 24 to 48 hrs. after study drug infusion
Longevity of EF5 adducts as measured by EF5 binding

Full Information

First Posted
July 8, 2002
Last Updated
April 30, 2015
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00041028
Brief Title
EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage 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

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue. PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES: Assess the frequency and degree of hypoxia as measured by etanidazole derivative EF5 binding in patients with stage I, II, or III non-small cell lung cancer. Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers and tissue markers of hypoxia in these patients. Correlate hypoxia as measured by EF5 binding with tumor angiogenesis and apoptosis in these patients. Correlate tumor perfusion with hypoxia in these patients. Correlate tumor perfusion with microvessel density in tumor samples in these patients. Determine the longevity of EF5 adducts in human lung tumors. OUTLINE: Patients are stratified according to disease stage (stage I or II vs stage III vs no stage I-III determined after pathologic staging). Within 24-48 hours prior to the planned surgical procedure, patients receive etanidazole derivative EF5 IV over 1-2.5 hours. Tumor hypoxia is then measured using an intraoperative Eppendorf needle electrode during surgical biopsy or resection. Tumor specimens are tested for EF5 binding using immunohistochemistry and flow cytometry. Patients are followed at 4-6 weeks. PROJECTED ACCRUAL: A total of 40-60 patients (20 with stage I/II disease, 20 with stage III disease, and 20 without stage I-III disease) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EF5
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Primary Outcome Measure Information:
Title
Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion
Secondary Outcome Measure Information:
Title
Correlation of hypoxia with serum/plasma markers of hypoxia, tissue markers of hypoxia, tumor angiogenesis, apoptosis, tumor perfusion, and microvessel density at 24 to 48 hrs. after study drug infusion
Title
Longevity of EF5 adducts as measured by EF5 binding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed or suspected non-small cell lung cancer (NSCLC) If there is no histological or cytological documentation of NSCLC, must have at least a 75% probability of having NSCLC Clinical or pathological stage I-III Patients in whom pre-surgical staging has not definitively established stage IV disease are allowed Tumor mass of ≥ 1.5 cm in maximum diameter must be present on CT scan and must be included in the planned surgical biopsy or resection Must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not specified Hematopoietic: WBC > 2,000/mm^3 Platelet count > 100,000/mm^3 Hepatic: Bilirubin normal Renal: Creatinine normal OR Creatinine clearance ≥ 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study participation Able to hold breath for 27 seconds No allergy to IV contrast dye No history of grade III or IV peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Kelley, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

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