A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865, IND #7921) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus
PRIMARY OBJECTIVES:
I. To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel
reduces the progression-free survival (PFS) event rate when compared to
gemcitabine-docetaxel plus placebo in patients with advanced or recurrent uterine
leiomyosarcoma (LMS).
SECONDARY OBJECTIVES:
I. To determine the objective response rate, as measured by RECIST, of patients treated with
fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response
rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo.
II. To determine if the addition of bevacizumab to the combination of gemcitabine and
docetaxel increases overall survival in patients with advanced or recurrent uterine LMS.
III. To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and
without bevacizumab in this patient population.
IV. To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
whole-pelvic radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride
IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also
receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine
hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8.
Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Duration of progression-free survival
Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
Up to 5 years
No
Martee Hensley
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2010-01738
NCT01012297
November 2009
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Mayo Clinic | Rochester, Minnesota 55905 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Mount Sinai Medical Center | New York, New York 10029 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Munson Medical Center | Traverse City, Michigan 49684 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Mercy Hospital | Miami, Florida 33133 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Gynecologic Oncology of Indiana | Indianapolis, Indiana 46237 |
South Bend Clinic | South Bend, Indiana 46617 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Beebe Medical Center | Lewes, Delaware 19958 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Longmont United Hospital | Longmont, Colorado 80501 |
Aurora Sinai Medical Center | Milwaukee, Wisconsin 53201-0342 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Memorial Medical Center | Springfield, Illinois 62781 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Hennepin County Medical Center | Minneapolis, Minnesota |
University of California at San Diego | La Jolla, California 92093 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Wayne State University | Detroit, Michigan 48202 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Southern California | Los Angeles, California 90033 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
University of California San Francisco Medical Center-Mount Zion | San Francisco, California 94115 |
The Medical Center of Aurora | Aurora, Colorado 80012 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Saint Anthony Central Hospital | Denver, Colorado 80204 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Mary Corwin Medical Center | Pueblo, Colorado 81004 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Memorial Medical Center - Las Cruces | Las Cruces, New Mexico 88011 |
Kettering Medical Center | Kettering, Ohio 45429 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center-Oncology Clinic | Sioux Falls, South Dakota 57104 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Magee-Womens Hospital of UPMC | Pittsburgh, Pennsylvania 15213 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Elkhart Clinic | Elkhart, Indiana 46515 |
John Muir Medical Center-Concord Campus | Concord, California 94520 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Michiana Hematology Oncology PC-Elkhart | Elkhart, Indiana 46514 |
Michiana Hematology Oncology PC-Plymouth | Plymouth, Indiana 46563 |
Michiana Hematology Oncology PC-South Bend | South Bend, Indiana 46601 |
Michiana Hematology Oncology-PC Westville | Westville, Indiana 46391 |
Michiana Hematology Oncology PC-Niles | Niles, Michigan 49120 |
Carolinas Medical Center - Northeast | Concord, North Carolina 28025 |
Olive View-University of California Los Angeles Medical Center | Sylmar, California 91342 |
Center of Hope at Renown Medical Center | Reno, Nevada 89502 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Aurora Women's Pavilion of Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |
Kaiser Permanente Los Angeles Medical Center | Los Angeles, California 90027 |
Rocky Mountain Gynecologic Oncology PC | Englewood, Colorado 80110 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
Norton Health Care Pavilion - Downtown | Louisville, Kentucky 40202 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Walter Reed National Military Medical Center | Bethesda, Maryland 20889 |
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California 94040 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Jonsson Comprehensive Cancer Center | Los Angeles, California 90095 |
Michiana Hematology Oncology PC-Mishawaka | Mishawaka, Indiana 46545-1470 |
Marie Yeager Cancer Center | Saint Joseph, Michigan 49085 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Gynecologic Oncology Group | Philadelphia, Pennsylvania 19103 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Georgia Regents University | Augusta, Georgia 30912 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Saint Joseph's Hospital and Medical Center | Phoenix, Arizona 85013 |
Kaiser Permanente Medical Care Program - Los Angeles Medical Center & Sunset Hospital | Los Angeles, California 90027 |
The James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Women's Cancer Care Associates LLC | Albany, New York 12208 |
Fletcher Allen Health Care-Medical Center | Burlington, Vermont 05401 |
Cancer Center of Western Wisconsin | New Richmond, Wisconsin 54017 |
Baylor All Saints Medical Center at Fort Worth | Fort Worth, Texas 76104 |
Baptist Health Lexington | Lexington, Kentucky 40503 |
Lahey Hospital and Medical Center | Burlington, Massachusetts 01805 |