A Phase 2 interventional study of EF5 in Primary Peritoneal Cavity Cancer, Stage I Endometrial Carcinoma and Stage I Ovarian Epithelial Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Diagnostic
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
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 60 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,505 studies on the registry; 333 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Inclusion Criteria:
Histologically confirmed* diagnosis of 1 of the following:
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.
Drug: EF5
Given IV
Level of EF5 binding
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time frame: Baseline
Hemoglobin level
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time frame: Baseline
Time to progression
Analyzed using Kaplan-Meier procedures.
Time frame: Up to 1 year
Time to recurrence
Analyzed using Kaplan-Meier procedures.
Time frame: Up to 1 year
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)