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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have recurrent or persistent cancer of the uterus.

Condition	Treatment or Intervention	Phase
recurrent uterine sarcoma uterine leiomyosarcoma	Drug: docetaxel  Drug: filgrastim  Drug: gemcitabine  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) in patients with persistent or recurrent uterine leiomyosarcoma.
• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 90 minutes on days 1 and 8, docetaxel IV over 1 hour on day 8, and filgrastim (G-CSF) subcutaneously on days 9-15. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine leiomyosarcoma
• Recurrent or persistent disease that is refractory to curative therapy or established treatments
• Must have received 1 prior chemotherapy regimen that may include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
• At least 1 unidimensionally measurable lesion
• At least 20 mm by conventional techniques OR
• At least 10 mm by spiral CT scan
• Outside prior irradiated field
• Ineligible for a high priority GOG protocol

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.1 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No active infection requiring antibiotics
• No motor or sensory neuropathy greater than grade 1
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies,cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease
• At least 3 weeks since prior biologic or immunologic therapy for this disease

Chemotherapy:

• See Disease Characteristics
• See Biologic therapy
• At least 3 weeks since prior chemotherapy and recovered
• No prior docetaxel or gemcitabine
• No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial regimens
• No prior chemotherapy for another malignancy that would preclude study

Endocrine therapy:

• At least 1 week since prior hormonal therapy for this disease
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics
• Recovered from prior recent surgery

Other:

• At least 3 weeks since other prior therapy for this disease
• No concurrent amifostine or other protective agents

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States
California
      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States
      Women's Cancer Center at Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
      Memorial Medical Center, Springfield,  Illinois,  62794-9640,  United States
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612-3824,  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
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Massachusetts
      Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0526,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
      Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States
Tennessee
      Genecologic Oncology Network, Nashville,  Tennessee,  37203,  United States
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway
United Kingdom, England
      Queen Elizabeth Hospital at University of Birmingham, Birmingham,  England,  B15 2TH,  United Kingdom

Study chairs or principal investigators

Martee L. Hensley, MD,  Study Chair,  Novartis Pharma, AG Switzerland   

Study ID Numbers:  CDR0000069206; GOG-0131G
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00031629
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08