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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EF5
immunohistochemistry staining method
biopsy
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Colorado Gynecologic Oncology Group P.C.
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • Oklahoma University Medical Center
  • Cancer Care Associates - Midtown Tulsa

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
June 21, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00049231
Brief Title
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

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EF5
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
biopsy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Colorado Gynecologic Oncology Group P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates - Midtown Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States

12. IPD Sharing Statement

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

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