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Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Phase 2
Terminated
Conditions
Cervical Cancer
Registration Number
NCT00006224
Lead Sponsor
Gynecologic Oncology Group
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.

* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1 year.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (39)

Jonsson Comprehensive Cancer Center, UCLA

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

University of Chicago Cancer Research Center

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Chicago, Illinois, United States

Ireland Cancer Center

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Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

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Cleveland, Ohio, United States

Arthur G. James Cancer Hospital - Ohio State University

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Columbus, Ohio, United States

Fox Chase Cancer Center

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Philadelphia, Pennsylvania, United States

Tufts University School of Medicine

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Boston, Massachusetts, United States

Indiana University Cancer Center

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Indianapolis, Indiana, United States

University of Mississippi Medical Center

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Jackson, Mississippi, United States

Medical University of South Carolina

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Charleston, South Carolina, United States

Walter Reed Army Medical Center

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Washington, District of Columbia, United States

Cooper Hospital/University Medical Center

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Camden, New Jersey, United States

Brookview Research, Inc.

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Nashville, Tennessee, United States

Tom Baker Cancer Center - Calgary

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Calgary, Alberta, Canada

University of Alabama at Birmingham Comprehensive Cancer Center

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Birmingham, Alabama, United States

Community Hospital of Los Gatos

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Los Gatos, California, United States

H. Lee Moffitt Cancer Center and Research Institute

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Tampa, Florida, United States

Chao Family Comprehensive Cancer Center

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Orange, California, United States

Ellis Fischel Cancer Center

πŸ‡ΊπŸ‡Έ

Columbia, Missouri, United States

Duke Comprehensive Cancer Center

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Durham, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

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Winston-Salem, North Carolina, United States

Barrett Cancer Center, The University Hospital

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Cincinnati, Ohio, United States

Abington Memorial Hospital

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Abington, Pennsylvania, United States

University of Pennsylvania Cancer Center

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Philadelphia, Pennsylvania, United States

Simmons Cancer Center - Dallas

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Dallas, Texas, United States

Cancer Center at the University of Virginia

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Charlottesville, Virginia, United States

Fletcher Allen Health Care - Medical Center Campus

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Burlington, Vermont, United States

Tacoma General Hospital

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Tacoma, Washington, United States

Rush-Presbyterian-St. Luke's Medical Center

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Chicago, Illinois, United States

Holden Comprehensive Cancer Center at The University of Iowa

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Iowa City, Iowa, United States

Ellis Fischel Cancer Center - Columbia

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Columbia, Missouri, United States

State University of New York Health Science Center at Brooklyn

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Brooklyn, New York, United States

Albert B. Chandler Medical Center, University of Kentucky

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Lexington, Kentucky, United States

Barbara Ann Karmanos Cancer Institute

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Detroit, Michigan, United States

Lineberger Comprehensive Cancer Center, UNC

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Chapel Hill, North Carolina, United States

Cancer Center of Albany Medical Center

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Albany, New York, United States

University of Oklahoma College of Medicine

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Oklahoma City, Oklahoma, United States

Milton S. Hershey Medical Center

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Hershey, Pennsylvania, United States

Washington University School of Medicine

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Saint Louis, Missouri, United States

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