EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
NCT ID: NCT00107445
Last Updated: 2013-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2005-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Treatment (EF5)
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.
EF5
Given IV
Interventions
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EF5
Given IV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Christina Chu
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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UPCC-03804
Identifier Type: -
Identifier Source: secondary_id
CDR0000419673
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02649
Identifier Type: -
Identifier Source: org_study_id
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