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Completed

NCT Number: NCT00107445

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EF5

Drug

Given IV

Primary outcomes

  1. Level of EF5 binding

    Time frame: Baseline

    The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.

  2. Hemoglobin level

    Time frame: Baseline

    The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.

  3. Time to progression

    Time frame: Up to 1 year

    Analyzed using Kaplan-Meier procedures.

  4. Time to recurrence

    Time frame: Up to 1 year

    Analyzed using Kaplan-Meier procedures.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer

Important dates

Study start
2005
Primary completion
2005
First posted
Apr 6, 2005
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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