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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)

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