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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Michael J. Kelley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

Pro00011318

NCT ID:

NCT00041028

Start Date:

May 2002

Completion Date:

Related Keywords:

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

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705