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

Sponsor:	Duke Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00041028

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: EF5 Other: flow cytometry Other: immunohistochemistry staining method	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Diagnostic
Official Title:	Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Etanidazole

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]
Longevity of EF5 adducts as measured by EF5 binding [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041028

Locations

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27705
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Michael J. Kelley, MD

Duke Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00041028 History of Changes
Other Study ID Numbers:	CDR0000069437, DUMC-0041-M1RB00622, NCI-2310
Study First Received:	July 8, 2002
Last Updated:	December 13, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012