Clinical Trial: Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

This study has been suspended.

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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

Condition Treatment or Intervention Phase
recurrent cervical cancer
cervical squamous cell carcinoma
stage IVA cervical cancer
stage IVB cervical cancer
 Procedure: chemotherapy
 Drug: cisplatin
 Drug: gemcitabine
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Gemcitabine and Cisplatin in Patients With Refractory or Recurrent Squamous Cell Carcinoma of the Cervix

Further Study Details: 

Study start: January 2001

OBJECTIVES: I. Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix. II. Determine the nature and degree of toxicity of this regimen in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days 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: A total of 28-69 patients will be accrued for this study.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: Not specified
  • Performance status: GOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: Platelet count at least lower limit of normal; Absolute neutrophil 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 2.0 mg/dL
  • Other: Not pregnant; Fertile patients must use effective contraception; No significant infection; No other malignancies within past 5 years except nonmelanoma 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

      Rational Therapeutics Inc., Long Beach,  California,  90807,  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 Illinois College of Medicine at Peoria, Peoria,  Illinois,  61603,  United States

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

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

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

      Schneider Children's Hospital at North Shore, Manhasset,  New York,  11030,  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

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

Cheryl A. Brewer,  Study Chair,  Gynecologic Oncology Group   

More Information

Study ID Numbers:  CDR0000068313; GOG-0127Q
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  November 6, 2000
ClinicalTrials.gov Identifier:  NCT00006482
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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