Clinical trial NCT00049231: EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
Official title: Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
state: Arkansas
city: Denver
country: United States
facility: Colorado Gynecologic Oncology Group P.C.
state: Colorado
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center at University of Missouri - Columbia
state: Missouri
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates - Midtown Tulsa
state: Oklahoma
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
role: STUDY_CHAIR
References: