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
4 other identifiers
interventional
60
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 5, 2005
CompletedFirst Posted
Study publicly available on registry
April 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedJanuary 16, 2013
January 1, 2013
7 months
April 5, 2005
January 15, 2013
Conditions
Outcome Measures
Primary Outcomes (4)
Level of EF5 binding
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Baseline
Hemoglobin level
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Baseline
Time to progression
Analyzed using Kaplan-Meier procedures.
Up to 1 year
Time to recurrence
Analyzed using Kaplan-Meier procedures.
Up to 1 year
Study Arms (1)
Treatment (EF5)
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed\* diagnosis of 1 of the following:
- Cervical cancer
- Ovarian epithelial cancer
- Endometrial cancer
- Peritoneal cavity cancer
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Chu
Abramson Cancer Center at Penn Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2005
First Posted
April 6, 2005
Study Start
February 1, 2005
Primary Completion
September 1, 2005
Last Updated
January 16, 2013
Record last verified: 2013-01