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	Treatment or Intervention
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer	Drug: EF5  Procedure: biopsies  Procedure: diagnostic test  Procedure: immunohistochemistry

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
North Carolina
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
Oklahoma
      Cancer Care Associates - Saint Francis Campus, Tulsa,  Oklahoma,  74136,  United States; Recruiting
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting

Study chairs or principal investigators

Gillian Monica Thomas, BSc, MD, FRCPC,  Study Chair,  Toronto Sunnybrook Regional Cancer Centre   

Study ID Numbers:  CDR0000258053; GOG-8002; NCT00049231
Record last reviewed:  June 2004
Last Updated:  April 4, 2005
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049231
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08