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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus  Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
For Condition: recurrent uterine sarcoma,uterine leiomyosarcoma
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarteeHensley, Study Chair, Novartis Pharma, AG Switzerland
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-2516
United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, 37917
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1740
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0526
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Women's Cancer Center at Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Genecologic Oncology Network
Nashville, Tennessee, 37203
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, 11790-7775
United States
Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, B15 2TH
United Kingdom
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3824
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6188
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, 39534-2576
United States
Memorial Medical Center
Springfield, Illinois, 62794-9640
United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Additional Information:
Study ID Numbers: CDR0000069206; GOG-0131G
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031629
Other Recurrent Uterine Sarcoma Studies:
1. Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
2. Paclitaxel in Treating Patients With Recurrent or Persistent Cancer of the Uterus
3. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
4. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
5. Chemotherapy in Treating Patients With Sarcoma of the Uterus
Related Studies:
Other recurrent uterine sarcoma Clinical Trials
Other Illinois Clinical Trials
Other Springfield Clinical Trials
Combination Chemotherapy and Filgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus
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