Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
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.
Inclusion Criteria:
Histologically confirmed* diagnosis of 1 of the following:
Requires surgery or biopsy for diagnosis or as standard initial treatment for the tumor
Performance status - ECOG 0-2
WBC ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal
Creatinine normal
Creatinine clearance ≥ 60 mL/min
No significant cardiac condition that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study participation
Weight ≤ 130 kg
No other significant medical condition that would preclude study participation
No scheduled chemotherapy for the tumor within the past 3 months
No scheduled radiotherapy to the tumor within the past 3 months
No other concurrent investigational agents