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 topotecan in treating patients with recurrent or refractory cancer of the uterus.

Condition	Treatment or Intervention	Phase
recurrent uterine sarcoma uterine carcinosarcoma	Drug: topotecan	Phase II

Further Study Details: 

OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients.

PROTOCOL OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death.

PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven recurrent or refractory carcinosarcoma (mixed mesodermal tumors) of the uterus
• Measurable disease

--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 topotecan or camptothecin therapy; No more than 1 prior chemotherapy regimen (either single or combination chemotherapy)
• Endocrine therapy: At least 3 weeks since prior endocrine therapy
• Radiotherapy: At least 3 weeks since prior radiotherapy and recovered
• Surgery: Prior surgery allowed and recovered

--Patient Characteristics--

• Age: Not specified
• Performance Status: GOG 0-2
• Life Expectancy: Not specified
• Hematopoietic: Platelet count at least 100,000/mm3; Absolute granulocyte count at least 1,500/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 3 times ULN; Alkaline phosphatase no greater than 3 times ULN
• Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance greater than 20 mL/min
• Other: No invasive malignancies within the past 5 years except nonmelanomatous skin cancer; No significant infection

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  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,  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
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
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-7775,  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
      CCOP - Sooner State, Tulsa,  Oklahoma,  74136,  United States
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  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
Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States
      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
Vermont
      Fletcher Allen Health Care, Burlington,  Vermont,  05401,  United States
Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States
Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada

Study chairs or principal investigators

David Scott Miller,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000065948; GOG-130D
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 6, 2000
ClinicalTrials.gov Identifier:  NCT00003156
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08