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

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

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 Other: immunohistochemistry staining method Procedure: biopsy

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Etanidazole

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000258053, GOG-8002
Study First Received:	November 12, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00049231 History of Changes
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:

Uterine Cervical Neoplasms
Epidermoid Carcinoma
Squamous Cell Carcinoma
Adenocarcinoma

Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009