A Phase II Evaluation Of Docetaxel And Gemcitabine Plus G-CSF In The Treatment Of Recurrent Or Persistent Leiomyosarcoma Of The Uterus
OBJECTIVES:
- Determine the antitumor activity of docetaxel, gemcitabine, and filgrastim (G-CSF) or
pegfilgrastim 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 (SC) on days 9-15 or pegfilgrastim SC
on day 9 only. 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.
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
CDR0000069206
NCT00031629
January 2002
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
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 |
Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
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 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
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 |
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
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 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
Banner Thunderbird Medical Center | Phoenix, Arizona 85306 |
Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Mount Carmel West Hospital | Columbus, Ohio 43222 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven, Connecticut 06520-8064 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Colorado Gynecologic Oncology Group P.C. | Aurora, Colorado 80010 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Rocky Mountain Gynecologic Oncology | Englewood, Colorado 80110 |