EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
Summary
RATIONALE: Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment.
PURPOSE: 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.
Description
OBJECTIVES:
Primary
- 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
- Correlate pre-treatment tumor hypoxia (as measured by EF5 binding) with time to progression and time to recurrence in these patients.
- 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.
PROJECTED ACCRUAL: Approximately 60 patients (12 with cervical cancer and 24 each with ovarian epithelial and endometrial cancer) will be accrued for this study within 2 years.
Study Design
Primary Purpose: Diagnostic
Conditions
Cervical Cancer
Intervention
EF5, flow cytometry, immunohistochemistry staining method, biopsy, conventional surgery
Location
Abramson Cancer Center of the University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104-4283
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00107445
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:53:26-0400
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Medical and Biotech [MESH] Definitions
Image Cytometry
A technique encompassing morphometry, densitometry, neural networks, and expert systems that has numerous clinical and research applications and is particularly useful in anatomic pathology for the study of malignant lesions. The most common current application of image cytometry is for DNA analysis, followed by quantitation of immunohistochemical staining.
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Fluorophotometry
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