RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma.

Condition	Treatment or Intervention	Phase
recurrent uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma uterine leiomyosarcoma	Drug: docetaxel  Drug: filgrastim  Drug: gemcitabine  Drug: pegfilgrastim  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) or pegfilgrastim in patients with advanced, persistent, or recurrent uterine leiomyosarcoma.
• Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28 months.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed uterine leiomyosarcoma
• Advanced, persistent, or recurrent disease
• Documented disease progression
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• At least 1 target lesion
• Tumors within a previously irradiated field are considered nontarget lesions
• Ineligible for higher priority GOG protocols (i.e., any active phase III GOG protocol for the same patient population)

PATIENT CHARACTERISTICS: Age

• Adult

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No neuropathy (sensory or motor) > grade 1
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No active infection requiring antibiotics
• No known hypersensitivity to E. coli-derived proteins

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy for the malignancy

Endocrine therapy

• At least 1 week since prior hormonal therapy for the malignancy
• Concurrent hormone replacement therapy allowed

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy

Surgery

• Recovered from prior surgery

Other

• Recovered from all other prior therapy
• No prior cancer treatment that would preclude study treatment
• No concurrent amifostine or other protective agents

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
Delaware
      Helen F. Graham Cancer Center, Newark,  Delaware,  19713,  United States; Recruiting
Georgia
      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31403-3089,  United States; Recruiting
Illinois
      Carle Clinic Association, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      Hinsdale Hematology Oncology Associates, Hinsdale,  Illinois,  60521,  United States; Recruiting
      Joliet Oncology Hematology Associates, Limited - West, Joliet,  Illinois,  60435,  United States; Recruiting
      Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting
      Rush-Copley Cancer Care Center, Aurora,  Illinois,  60504-4206,  United States; Recruiting
      Hinsdale,  Illinois,  60521,  United States; Recruiting
      St. Anthony's Memorial Hospital, Effingham,  Illinois,  62401,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Louisiana
      Woman's Hospital, Baton Rouge,  Louisiana,  70815,  United States; Recruiting
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      Cox Medical Center North, Springfield,  Missouri,  65802,  United States; Recruiting
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
      Hulston Cancer Center at Cox Medical Center South, Springfield,  Missouri,  65807,  United States; Recruiting
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
      St. John's Regional Health Center, Springfield,  Missouri,  65804-2263,  United States; Recruiting
Nebraska
      Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha,  Nebraska,  68114,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
New Mexico
      University of New Mexico Cancer Research and Treatment Center, Albuquerque,  New Mexico,  87131-5636,  United States; Recruiting
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
      New York Oncology Hematology, P.C. at Capital District Hematology Oncology Associates, P.C. - Albany, Albany,  New York,  12208,  United States; Recruiting
      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
      Hope A Women's Cancer Center, Asheville,  North Carolina,  28816,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
      Mission Hospitals, Asheville,  North Carolina,  28801,  United States; Recruiting
Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
      Riverside Methodist Hospital Cancer Care, Columbus,  Ohio,  43214-3998,  United States; Recruiting
Oklahoma
      Cancer Care Associates - Midtown Tulsa, Tulsa,  Oklahoma,  74104-4611,  United States; Recruiting
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      Drexel University College of Medicine - Center City Hahnemann Campus, Philadelphia,  Pennsylvania,  19102-1101,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
Rhode Island
      Women and Infants Hospital of Rhode Island, Providence,  Rhode Island,  02905,  United States; Recruiting
South Carolina
      University of South Carolina School of Medicine, Columbia,  South Carolina,  29203,  United States; Recruiting

Study chairs or principal investigators

Martee L. Hensley, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   
Gregory P. Sutton, MD,  St. Vincent Oncology Center   

Study ID Numbers:  CDR0000405892; GOG-0087L; NCT00101127
Record last reviewed:  February 2005
Last Updated:  April 4, 2005
Record first received:  January 7, 2005
ClinicalTrials.gov Identifier:  NCT00101127
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08