Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Completed	18 and over	NCI	GOG-8002 NCT00049231

Objectives

1. 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.
2. Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated with overall survival, progression-free interval, and local control in these patients.
3. 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 Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Gillian Thomas, BSc, MD, FRCPC, FRCR (Hon), Protocol chair		Ph: 416-480-6165

Related Information

PDQ® clinical trial GOG-0191

Registry Information
Official Title		Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer
Trial Start Date		2003-06-27
Registered in ClinicalTrials.gov		NCT00049231
Date Submitted to PDQ		2002-09-11
Information Last Verified		2005-06-02
NCI Grant/Contract Number		U10-CA27469

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