Spots Global Cancer Trial Database for Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma
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Trial Identification
Brief Title: Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma
Official Title: A Phase II Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
Study ID: NCT00101127
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital, Hartford, Connecticut, United States
New Britain General Hospital, New Britain, Connecticut, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Woman's Hospital, Baton Rouge, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
St. John's Regional Health Center, Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri, United States
Methodist Cancer Center at Methodist Hospital - Omaha, Omaha, Nebraska, United States
Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey, United States
UMDNJ University Hospital, Newark, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care, Albany, New York, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
Hope A Women's Cancer Center, Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
Lake/University Ireland Cancer Center, Mentor, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa, Tulsa, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Drexel University College of Medicine - Center City Hahnemann Campus, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Baptist Centers for Cancer Care, Memphis, Tennessee, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Contact Details
Name: Martee L. Hensley, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Name: Gregory P. Sutton, MD
Affiliation: St. Vincent Gynecologic Oncology at St. Vincent Oncology Center
Role:
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