Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041028 |
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 Procedure: flow cytometry Procedure: immunohistochemistry staining method |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | May 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed or suspected non-small cell lung cancer (NSCLC)
Clinical or pathological stage I-III
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
Study Chair: | Michael J. Kelley, MD | Duke University |
Study ID Numbers: | CDR0000069437, DUMC-0041-M1RB00622, NCI-2310 |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00041028 |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |