Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT00107445
This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment
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Notify Me18 year and older
Female
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
PRIMARY OBJECTIVES:
I. Correlate the level of EF5 binding with pre-treatment hemoglobin level and tumor grade and stage in patients undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer.
SECONDARY OBJECTIVES:
I. Correlate pre-treatment tumor hypoxia (as measured by EF5 binding) with time to progression and time to recurrence in these patients.
II. Correlate EF5 binding with CD-31 expression (tumor vasculature), Ki-67 expression (cellular proliferation), and erythropoietin signaling in these patients.
OUTLINE:
Patients receive EF5 IV over 1-2½ hours on day 1. Approximately 1-2 days later, patients undergo tumor resection or biopsy. Patients' tumor tissue samples undergo immunohistochemistry and flow cytometry to detect EF5 binding levels. Patients' blood is drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure systemic EF5 binding levels.
Patients are followed at 30-45 days after administration of EF5 and then every 3-6 months thereafter.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Given IV
Time frame: Baseline
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time frame: Baseline
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time frame: Up to 1 year
Analyzed using Kaplan-Meier procedures.
Time frame: Up to 1 year
Analyzed using Kaplan-Meier procedures.
National Cancer Institute (NCI)
Nih
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
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