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

Purpose

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.

Condition	Intervention
Cervical Cancer	Drug: EF5 Procedure: biopsy Procedure: immunohistochemistry staining method

MedlinePlus related topics:

Cancer Cervical Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label

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

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

Study Start Date:

June 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049231

Locations


United States, Arkansas
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
	Little Rock, Arkansas, United States, 72205

United States, Colorado
	Colorado Gynecologic Oncology Group P.C.
	Denver, Colorado, United States, 80218

United States, Missouri
	Ellis Fischel Cancer Center at University of Missouri - Columbia
	Columbia, Missouri, United States, 65203

United States, Oklahoma
	Cancer Care Associates - Midtown Tulsa
	Tulsa, Oklahoma, United States, 74104
	Oklahoma University Medical Center
	Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)	Edmond Odette Cancer Centre at Sunnybrook

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000258053, GOG-8002
First Received:	November 12, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00049231
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical adenocarcinoma

cervical adenosquamous cell carcinoma

cervical squamous cell carcinoma

stage IIB cervical cancer

stage III cervical cancer

stage IVA cervical cancer

Study placed in the following topic categories:

Squamous cell carcinoma

Genital Neoplasms, Female

Uterine Diseases

Urogenital Neoplasms

Carcinoma

Epidermoid carcinoma

Uterine Cervical Neoplasms

Genital Diseases, Female

Uterine Cervical Diseases

Carcinoma, squamous cell

Uterine Neoplasms

Carcinoma, Squamous Cell

Adenocarcinoma

Carcinoma, Adenosquamous

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049231