EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049231
• Other study ID #: CDR0000258053
• Secondary ID: GOG-8002
• Status: Completed
• Phase: N/A
• First received: November 12, 2002
• Last updated: June 21, 2013
• Start date: June 2003
• Est. completion date: August 2005

Study information

• Verified date: June 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy.

PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.

Description:

OBJECTIVES:

• Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level, tumor size, and stage of disease in patients with stage IIB, IIIB, or IVA cervical cancer.

• Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated with overall survival, progression-free interval, and local control in these patients.

• Determine the relationship between EF5 binding and CD-31 labeling (tumor vasculature) and Ki-67 labeling (cellular proliferation) in these patients.

OUTLINE: This is a multicenter study.

Patients receive EF5 IV over 1-2.5 hours on day 1. Tumor hypoxia is measured using immunohistochemical techniques. Biopsies are collected 1-2 days later. Blood is collected before EF5 is administered and again at the time of surgery.

Patients are followed approximately 1 month after surgery.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix

• Stage IIB, IIIB, or IVA

• Primary disease

• No prior treatment

• Must be enrolled on GOG-0191 protocol

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• GOG 0-3

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

• Alkaline phosphatase no greater than 3 times normal

• Hemoglobin less than 13 g/dL

Renal

• Creatinine no greater than 2 mg/dL

Cardiovascular

• No cardiac disease that would preclude safe administration of necessary fluid volumes

Pulmonary

• No chronic pulmonary disease that would preclude safe administration of necessary fluid volumes

Other

• No history of grade 3 or 4 peripheral neuropathy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Must weigh no more than 180 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• EF5

Other:
• immunohistochemistry staining method

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Colorado Gynecologic Oncology Group P.C.	Denver	Colorado
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,