EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
Study Details
Study Description
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
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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Correlate pre-treatment tumor hypoxia (as measured by EF5 binding) with time to progression and time to recurrence in these patients.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: EF5
Given IV
|
Outcome Measures
Primary Outcome Measures
- Level of EF5 binding [Baseline]
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
- Hemoglobin level [Baseline]
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
- Time to progression [Up to 1 year]
Analyzed using Kaplan-Meier procedures.
- Time to recurrence [Up to 1 year]
Analyzed using Kaplan-Meier procedures.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed* diagnosis of 1 of the following:
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Cervical cancer
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Ovarian epithelial cancer
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Endometrial cancer
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Peritoneal cavity cancer
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Requires surgery or biopsy for diagnosis or as standard initial treatment for the tumor
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Performance status - ECOG 0-2
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WBC ≥ 2,000/mm^3
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Platelet count ≥ 100,000/mm^3
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Bilirubin normal
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Creatinine normal
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Creatinine clearance ≥ 60 mL/min
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No significant cardiac condition that would preclude study participation
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception during and for 1 month after study participation
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Weight ≤ 130 kg
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No other significant medical condition that would preclude study participation
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No scheduled chemotherapy for the tumor within the past 3 months
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No scheduled radiotherapy to the tumor within the past 3 months
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No other concurrent investigational agents
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Christina Chu, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-02649
- UPCC-03804
- R21CA099346
- CDR0000419673