Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer
18 Years
N/A
Female
Cervical Cancer
Trial Information
Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Principal Investigator
Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
Investigator Role:
Study Chair
Investigator Affiliation:
Odette Cancer Centre at Sunnybrook
Authority:
United States: Federal Government
Study ID:
CDR0000258053
NCT ID:
NCT00049231
Start Date:
June 2003
Completion Date:
August 2005
Related Keywords:
- Cervical Cancer
- cervical adenocarcinoma
- cervical adenosquamous cell carcinoma
- cervical squamous cell carcinoma
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- Uterine Cervical Neoplasms
- Anoxia
Name | Location |
|---|---|
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
| Colorado Gynecologic Oncology Group P.C. | Aurora, Colorado 80010 |
