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 with recurrent or refractory cancer of the uterus.

Condition	Treatment or Intervention	Phase
uterine leiomyosarcoma recurrent uterine sarcoma	Drug: gemcitabine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.

PROTOCOL OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments; Failed local therapeutic measures and considered incurable
• Measurable disease
• Not eligible for a higher priority GOG protocol

--Prior/Concurrent Therapy--

• Biologic therapy: At least 3 weeks since prior biologic therapy
• Chemotherapy: At least 3 weeks since prior chemotherapy and recovered; No prior gemcitabine; No more than 1 prior chemotherapy regimen (single agent or combination therapy)
• Endocrine therapy: At least 3 weeks since prior endocrine therapy
• Radiotherapy: At least 3 weeks since prior radiotherapy and recovered
• Surgery: At least 3 weeks since prior surgery and recovered

--Patient Characteristics--

• Age: 18 and over
• Performance status: GOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3
• Hepatic: Bilirubin no greater than 1.5 times normal; SGOT no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal
• Renal: Creatinine no greater than 1.5 mg/dL
• Other: No significant infection; At least 5 years since any other invasive malignancy except nonmelanoma skin cancer

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States
California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  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,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Maryland
      Radiation Oncology Branch, Bethesda,  Maryland,  20892,  United States
Massachusetts
      Tufts University School of Medicine, Boston,  Massachusetts,  02111,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  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 of Wake Forest University Baptist Medical Center, 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,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  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
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States
Canada, Ontario
      NCIC-Clinical Trials Group, Kingston,  Ontario,  K7L 3N6,  Canada

Study chairs or principal investigators

Katherine Yvonne Look,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000066265; GOG-131E
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 6, 2000
ClinicalTrials.gov Identifier:  NCT00003316
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08