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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107445
First received: April 5, 2005
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
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
Drug: EF5
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Level of EF5 binding [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.

  • Hemoglobin level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.

  • Time to progression [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Analyzed using Kaplan-Meier procedures.

  • Time to recurrence [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Analyzed using Kaplan-Meier procedures.


Enrollment: 60
Study Start Date: February 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107445

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Christina Chu Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00107445     History of Changes
Other Study ID Numbers: NCI-2012-02649, UPCC-03804, R21CA099346, CDR0000419673
Study First Received: April 5, 2005
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Peritoneal Neoplasms
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 17, 2014