Cervical Cancer
Conditions
Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer
Brief 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.
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed