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EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer

Primary Purpose

Primary Peritoneal Cavity Cancer, Stage I Endometrial Carcinoma, Stage I Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EF5
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 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

Sites / Locations

  • Abramson Cancer Center of The University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (EF5)

Arm Description

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.

Outcomes

Primary Outcome Measures

Level of EF5 binding
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Hemoglobin level
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time to progression
Analyzed using Kaplan-Meier procedures.
Time to recurrence
Analyzed using Kaplan-Meier procedures.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2005
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00107445
Brief Title
EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
Official Title
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (EF5)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EF5
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Level of EF5 binding
Description
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time Frame
Baseline
Title
Hemoglobin level
Description
The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
Time Frame
Baseline
Title
Time to progression
Description
Analyzed using Kaplan-Meier procedures.
Time Frame
Up to 1 year
Title
Time to recurrence
Description
Analyzed using Kaplan-Meier procedures.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Chu
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer

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