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 paclitaxel in treating patients with recurrent or persistent cancer of the uterus.

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

Further Study Details: 

OBJECTIVES: I. Estimate the antitumor activity of paclitaxel in patients with metastatic or persistent leiomyosarcoma of the uterus who have failed treatment protocols of higher priority.

II. Determine the nature and degree of toxic effects of paclitaxel in this group of patients.

PROTOCOL OUTLINE: Patients receive a continuous infusion of paclitaxel once every 3 weeks over 3 hours.

Patients in complete remission, partial remission, or stable disease undergo at least 3 courses of paclitaxel. Paclitaxel continues until disease progression or adverse effects prohibit further treatment.

All patients are followed until death.

PROJECTED ACCRUAL: This study anticipates an annual accrual of approximately 25 patients over 2.5 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or established treatments
• Measurable disease required
• Must have failed local therapeutic measures and must be considered incurable
• Not eligible for GOG protocols of higher priority

--Prior/Concurrent Therapy--

• At least 3 weeks since prior therapy to malignant tumor
• Biologic therapy: Not specified
• Chemotherapy: Recovery from prior chemotherapy required; No more than 1 prior chemotherapy regimen allowed; No prior paclitaxel; No prior chemotherapy for any malignancy from which the patient is disease-free for at least 5 years
• Endocrine therapy: Not specified
• Radiotherapy: Recovery from prior radiation therapy required; No prior radiation therapy for any malignancy from which the patient is disease-free for at least 5 years
• Surgery: Recovery from prior surgery required

--Patient Characteristics--

• Age: Not specified
• Performance status: GOG 0-3
• 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 and alkaline phosphatase no greater than 3 times normal
• Renal: Creatinine no greater than 2.0 mg/dL
• Cardiovascular: No unstable angina within 6 months OR No myocardial infarction within 6 months; Abnormal cardiac condition (e.g., bundle branch block, heart block) allowed if stable for 6 months
• Other: No significant infection; No concomitant malignancy other than nonmelanomatous 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
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
      Women's Cancer Center, Palo Alto,  California,  94304,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
      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
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Medical College of Georgia Comprehensive Cancer Center, Augusta,  Georgia,  30912-4000,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Central Illinois, Springfield,  Illinois,  62526,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      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
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
      Medicine Branch, Bethesda,  Maryland,  20892,  United States
      Radiation Oncology Branch, Bethesda,  Maryland,  20892,  United States
Massachusetts
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  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
Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  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
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  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,  11790-9832,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
North Carolina
      Brookview Research, Inc., Winston Salem,  North Carolina,  27103,  United States
      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 Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa,  Oklahoma,  74136,  United States
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  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
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States
Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  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, Ontario
      NCIC-Clinical Trials Group, Kingston,  Ontario,  K7L 3N6,  Canada

Study chairs or principal investigators

Donald G. Gallup,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000065702; GOG-131C
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003054
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08