A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC#704865, IND#7921), Paclitaxel/Carboplatin/Temsirolimus (NSC#683864, IND#61010) and Ixabepilone (NSC#710428, IND#59699) / Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
PRIMARY OBJECTIVES:
I. To estimate the hazard of progression or death of each of the three arms relative to that
of historical controls in patients with advanced or recurrent endometrial cancer.
SECONDARY OBJECTIVES:
I. To determine the nature, frequency, and maximum degree of toxicity as assessed by CTCAE
v3.0 for each of the three arms.
II. To estimate the distribution of the duration of overall survival for each of the three
arms.
III. To estimate the proportion of patients with measurable disease who have confirmed
objective tumor responses by treatment.
TERTIARY OBJECTIVES:
I. To explore the associations between select biomarkers and progression-free survival as
well as secondary measures of clinical outcome (overall survival, tumor response, or disease
status if possible) in the context of histologic cell type and treatment.
II. To explore the relationship among the various biomarkers by histologic subtype and
treatment.
III. To explore which combination of biomarkers and clinical covariates optimally predicts
responsiveness and resistance to the three treatment arms.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and
bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses
in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients undergoing treatment post-surgery (≤ 12 weeks) receive bevacizumab beginning
on course 2.
ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on
day 1 and temsirolimus* IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days
for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive temsirolimus IV over 30 minutes on days 1, 8, and 15.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity.
NOTE: *Patients undergoing treatment post-surgery (≤ 12 weeks) receive temsirolimus
beginning on course 2.
ARM III: Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and
bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses
in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients undergoing treatment post-surgery (≤ 12 weeks) receive bevacizumab beginning
on course 2.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Up to 5 years
No
Carol Aghajanian
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-01969
NCT00977574
October 2009
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
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 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Hurley Medical Center | Flint, Michigan 48503 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
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 |
Akron General Medical Center | Akron, Ohio 44302 |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
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 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
John Muir Medical Center | Walnut Creek, California 94598 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Group Health Cooperative | Seattle, Washington 98112 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
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 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Beebe Medical Center | Lewes, Delaware 19958 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Morton Plant Hospital | Clearwater, Florida 33756 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
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 Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Sherman Hospital | Elgin, Illinois 60120-2198 |
Phelps County Regional Medical Center | Rolla, Missouri 65401 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
University of Virginia | Charlottesville, Virginia 22908 |
New York Hospital Medical Center of Queens | Fresh Meadows, New York 11365 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
University of California at San Diego | La Jolla, California 92093 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Yale University | New Haven, Connecticut 06520 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Northwest Hospital | Seattle, Washington 98133 |
Virginia Commonwealth University | Richmond, Virginia |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
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 |
Harrison Medical Center | Bremerton, Washington 98310 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Virginia Oncology Associates - Lake Wright | Norfolk, Virginia 23502 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Hawaii Medical Center East | Honolulu, Hawaii 96817 |
Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh, Wisconsin 54904 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
University of California San Francisco Medical Center-Mount Zion | San Francisco, California 94115 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Pacific Cancer Institute of Maui | Wailuku, Hawaii 96793 |
McFarland Clinic | Ames, Iowa 50010 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
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 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
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 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
Alamance Regional Medical Center | Burlington, North Carolina 27216 |
Kettering Medical Center | Kettering, Ohio 45429 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center-Oncology Clinic | Sioux Falls, South Dakota 57104 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Lyndon Baines Johnson General Hospital | Houston, Texas 77030 |
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 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Michiana Hematology Oncology PC-Niles | Niles, Michigan 49120 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
Renown Regional Medical Center | Reno, Nevada 89502 |
UMDNJ - New Jersey Medical School | Newark, New Jersey 07103 |
Virginia Oncology Associates-Hampton | Hampton, Virginia 23666 |
Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan, Wisconsin 53081 |
Hawaii Minority Based CCOP | Honolulu, Hawaii 96813 |
Maine Medical Center-Bramhall Campus | Portland, Maine 04102 |
Center of Hope at Renown Medical Center | Reno, Nevada 89502 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Hope, A Women's Cancer Center | Asheville, North Carolina 28816 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
Aurora Women's Pavilion of Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |
Rocky Mountain Gynecologic Oncology PC | Englewood, Colorado 80110 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
Saint Dominic-Jackson Memorial Hospital | Jackson, Mississippi 39216 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
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 |
University of Massachusetts Memorial Health Care | Worcester, Massachusetts 01605 |
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery | Phillipsburg, New Jersey 08865 |
PeaceHealth Medical Group PC | Bellingham, Washington 98226 |
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington 98274 |
Olympic Medical Cancer Care Center | Sequim, Washington 98384 |
Rockwood Cancer Treatment Center | Spokane, Washington 99204 |
Providence Saint Mary Regional Cancer Center | Walla Walla, Washington 99362 |
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
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 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Veterans Administration-San Diego Medical Center | San Diego, California 92161 |
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 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Saint Joseph's Hospital and Medical Center | Phoenix, Arizona 85013 |
The James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Women's Cancer Care Associates LLC | Albany, New York 12208 |
Island Gynecologic Oncology | Brightwaters, New York 11718 |
Fletcher Allen Health Care-Medical Center | Burlington, Vermont 05401 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
South Carolina Oncology Associates PA | Columbia, South Carolina 29210 |
Mercy Cancer Center-West Lakes | Clive, Iowa 50325 |
Mercy Medical Center-West Lakes | West Des Moines, Iowa 50266 |