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

NCT00049231 | Completed

• 2 other identifiers: CDR0000258053GOG-8002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

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

Interventions

EF5 DRUG

immunohistochemistry staining method OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Colorado Gynecologic Oncology Group P.C.

Denver, Colorado, 80218, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates - Midtown Tulsa

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2003
• Study Completion: August 1, 2005
• Last Updated: June 24, 2013

Record last verified: 2005-06

Locations

US (5)