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

Primary Peritoneal Cavity Cancer Clinical Trial

Official title:

Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107445
• Other study ID #: NCI-2012-02649
• Secondary ID: UPCC-03804R21CA0
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2005
• Last updated: January 15, 2013
• Start date: February 2005

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• 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
• Uterine Cervical Neoplasms

Intervention

Drug:
• EF5
Given IV

Locations

Country	Name	City	State
United States	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of EF5 binding	The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.	Baseline	No
Primary	Hemoglobin level	The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.	Baseline	No
Primary	Time to progression	Analyzed using Kaplan-Meier procedures.	Up to 1 year	No
Primary	Time to recurrence	Analyzed using Kaplan-Meier procedures.	Up to 1 year	No