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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: EF5
* Other: immunohistochemistry staining method
* Procedure: biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EF5|nan|
|Other: immunohistochemistry staining method|nan|
|Procedure: biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer