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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Gynecologic Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

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 .

Condition Treatment or Intervention Phase
recurrent cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
 Procedure: chemotherapy
 Drug: gemcitabine
Phase II

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Gemcitabine in Patients With Persistent or Recurrent Nonsquamous Cell Carcinoma of the Cervix

Further Study Details: 

Study start: September 2000

OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. II. Determine the toxicity of this regimen in these patients.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable; Eligible subtypes: Adenocarcinoma; Adenosquamous carcinoma; Undifferentiated carcinoma; Must have documented disease progression; Histologic confirmation of original primary tumor required
  • Bidimensionally measurable disease
  • Ineligible for higher priority GOG protocol

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: GOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3
  • Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal
  • Renal: Creatinine no greater than 1.5 mg/dL
  • Other: No significant infection; Not pregnant; Fertile patients must use effective contraception; No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer

Location Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States

California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States

Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

Iowa
      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States

Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

Massachusetts
      Tufts University School of Medicine, Boston,  Massachusetts,  02111,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

Missouri
      Ellis Fischel Cancer Center, Columbia,  Missouri,  65203,  United States

      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States

      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States

New Jersey
      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States

New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States

      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45267-0502,  United States

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States

      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States

South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States

Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States

Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States

Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada

Study chairs or principal investigators

Russell J. Schilder,  Study Chair,  Gynecologic Oncology Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068144; GOG-0128F
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006224
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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