Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information
EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Diagnostic | Completed | 18 and over | NCI | GOG-8002 NCT00049231 |
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.
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
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
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/mm3
- Platelet count at least 100,000/mm3
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
Expected Enrollment
A total of 150 patients will be accrued for this study within 3 years.
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.
Trial Lead Organizations
Gynecologic Oncology Group
 | | | |
| Gillian Thomas, BSc, MD, FRCPC, FRCR (Hon), Protocol chair | |
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Related Information
| Registry Information | ||
| ||
| Official Title | Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer | |
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| Trial Start Date | 2003-06-27 | |
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| Registered in ClinicalTrials.gov | NCT00049231 | |
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| Date Submitted to PDQ | 2002-09-11 | |
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| Information Last Verified | 2005-06-02 | |
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| NCI Grant/Contract Number | U10-CA27469 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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