Trials / Completed
CompletedNCT00107445
EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
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.
Conditions
- Primary Peritoneal Cavity Cancer
- Stage I Endometrial Carcinoma
- Stage I Ovarian Epithelial Cancer
- Stage IA Cervical Cancer
- Stage IB Cervical Cancer
- Stage II Endometrial Carcinoma
- Stage II Ovarian Epithelial Cancer
- Stage IIA Cervical Cancer
- Stage IIB Cervical Cancer
- Stage III Cervical Cancer
- Stage III Endometrial Carcinoma
- Stage III Ovarian Epithelial Cancer
- Stage IV Endometrial Carcinoma
- Stage IV Ovarian Epithelial Cancer
- Stage IVA Cervical Cancer
- Stage IVB Cervical Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EF5 | Given IV |
Timeline
- Start date
- 2005-02-01
- Primary completion
- 2005-09-01
- First posted
- 2005-04-06
- Last updated
- 2013-01-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00107445. Inclusion in this directory is not an endorsement.