NCT00049231

EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer

Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy. PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.

Detailed description

OBJECTIVES: * Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level, tumor size, and stage of disease in patients with stage IIB, IIIB, or IVA cervical cancer. * Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated with overall survival, progression-free interval, and local control in these patients. * Determine the relationship between EF5 binding and CD-31 labeling (tumor vasculature) and Ki-67 labeling (cellular proliferation) in these patients. OUTLINE: This is a multicenter study. Patients receive EF5 IV over 1-2.5 hours on day 1. Tumor hypoxia is measured using immunohistochemical techniques. Biopsies are collected 1-2 days later. Blood is collected before EF5 is administered and again at the time of surgery. Patients are followed approximately 1 month after surgery. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	EF5
OTHER	immunohistochemistry staining method
PROCEDURE	biopsy

Timeline

• Start date: 2003-06-01
• Completion: 2005-08-01
• First posted: 2003-01-27
• Last updated: 2013-06-24

Locations

5 sites across 1 country: United States