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Home > "E" Clinical Trials Conditions > EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer

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



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

For Condition: cervical squamous cell carcinoma,stage 2B cervical cancer,stage 4A cervical cancer,cervical adenocarcinoma,cervical adenosquamous cell carcinoma,stage 3 cervical cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GillianThomas,  Study Chair,  University of Toronto

Magee-Womens Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15213-3180
United States
Recruiting Joseph  Kelley 412-641-5418

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80010
United States
Recruiting Francis  Major 303-388-4876

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0526
United States
Recruiting Nader  Husseinzadeh 513-558-8450

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62794-9640
United States
Recruiting L.  Massad 217-545-8882

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

Cancer Care Associates - Saint Francis Campus *Recruiting*
Tulsa,  Oklahoma,  74136
United States
Recruiting Daron  Street 918-499-2000

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-2516
United States
Recruiting Marta  Crispens 615-322-2114

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Katherine  Look 317-274-8987

Saint Joseph Regional Medical Center *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Michael  Method 574-237-8010

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Anthony  Evans 715-389-3101

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

St. Vincent Hospital and Health Care Center *Recruiting*
Indianapolis,  Indiana,  46260
United States
Recruiting Hans  Geisler 317-338-3708

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Wesley  Fowler 919-966-1196

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364

University of Oklahoma College of Medicine *Recruiting*
Oklahoma City,  Oklahoma,  73190
United States
Recruiting Robert  Mannel 405-271-8787

Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville,  Tennessee,  37917
United States
Recruiting Kenneth  Cofer 865-673-9250

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Nava  Siegelmann-Danieli 570-271-6834

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Sara  Crowder 573-882-1057


Additional Information:
Study ID Numbers:
  CDR0000258053;  GOG-8002
Study Start Date: 
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049231

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