Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041028
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2002-07-08
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
Sponsor:
Duke University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 serumplasma 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 1-25 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 III disease 20 with stage III disease and 20 without stage I-III disease will be accrued for this study
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 serumplasma 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 1-25 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 III disease 20 with stage III disease and 20 without stage I-III disease will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069437 | OTHER | NCI | None |
| DUMC-0041-M1RB00622 | None | None | None |
| NCI-2310 | None | None | None |