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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity
No
Martee L. Hensley, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000405892
NCT00101127
December 2003
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia, Pennsylvania 19102 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
New Britain General Hospital | New Britain, Connecticut 06050 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Baptist Centers for Cancer Care | Memphis, Tennessee 38120 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |