Randomized Phase II Study of Paclitaxel With or Without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients With Metastatic Esophageal or GE Junction Cancer
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival of paclitaxel plus cixutumumab (IMC-A12) versus
paclitaxel alone as second-line therapy in patients with metastatic esophagus or GE junction
cancer.
SECONDARY OBJECTIVES:
I. To evaluate the overall survival of paclitaxel plus cixutumumab (IMC-A12) versus
paclitaxel alone in this patient population.
II. To evaluate the response rate of paclitaxel plus cixutumumab (IMC-A12) versus paclitaxel
alone in this patient population.
III. To evaluate the toxicity of cixutumumab (IMC-A12) plus paclitaxel versus paclitaxel
alone in this patient population.
IV. Exploratory analyses will assess potentially relevant cixutumumab (IMC-A12)
pharmacodynamic biomarkers obtained from serum samples, including but not limited to, IGF-I,
IGF-II, IGFBP-2, and IGFBP-3.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(gastroesophageal junction vs esophageal cancer) and cell type (squamous cell carcinoma vs
adenocarcinoma). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over I hour on days 1, 8, and 15.
ARM II: Patients receive cixutumumab IV over 1 hour on days 1 and 15, and paclitaxel as in
arm I.
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival of paclitaxel plus cixutumumab versus paclitaxel alone as second-line therapy in patients with metastatic esophagus or GE junction cancer
Up to 27 months
No
Steven Cohen
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-02045
NCT01142388
September 2010
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Mayo Clinic | Rochester, Minnesota 55905 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Hurley Medical Center | Flint, Michigan 48503 |
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 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
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 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
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 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Mercy Medical Center | Springfield, Ohio 45504 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Graham Hospital Association | Canton, Illinois 61520 |
Hematology Oncology Associates of Illinois-Highland Park | Highland Park, Illinois 60035 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Trinity Medical Center | Moline, Illinois 61265-1291 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Bixby Medical Center | Adrian, Michigan 49221 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
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 |
Saint Luke's Hospital | Maumee, Ohio 43537 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Swedish American Hospital | Rockford, Illinois 61104 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Longmont United Hospital | Longmont, Colorado 80501 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Memorial Medical Center | Springfield, Illinois 62781 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Northwestern University | Chicago, Illinois 60611 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Emory University | Atlanta, Georgia 30322 |
Cancer Center of Kansas - McPherson | McPherson, Kansas 67460 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Alegent Health Immanuel Medical Center | Omaha, Nebraska 68122 |
Alegent Health Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Butler Memorial Hospital | Butler, Pennsylvania 16001 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
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 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Provena Saint Mary's Hospital | Kankakee, Illinois 60901 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
West Suburban Cancer Center | River Forest, Illinois 60305 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis, Indiana 46202 |
Wishard Hospital | Indianapolis, Indiana 46202 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
McFarland Clinic | Ames, Iowa 50010 |
Cedar Rapids Oncology Association | Cedar Rapids, Iowa 52403 |
Mercy Hospital | Cedar Rapids, Iowa 52403 |
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 |
Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
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 |
Medical Center of Louisiana | New Orleans, Louisiana 70112 |
Hickman Cancer Center | Adrian, Michigan 49221 |
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 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
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 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
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 |
Lincoln Medical Education Foundation Cancer Resource Center | Lincoln, Nebraska 68510 |
Missouri Valley Cancer Consortium CCOP | Omaha, Nebraska 68106 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Veterans Adminstration New Jersey Health Care System | East Orange, New Jersey 07018-1095 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Saint Rita's Medical Center | Lima, Ohio 45801 |
Saint Charles Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
Mercy Cancer Center at Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
University of Toledo | Toledo, Ohio 43614 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Pottstown Memorial Medical Center | Pottstown, Pennsylvania 19464 |
Hematology and Oncology Associates of North East Pennsylvania | Scranton, Pennsylvania 18508 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Langlade Hospital and Cancer Center | Antigo, Wisconsin 54409 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Aspirus Regional Cancer Center | Wausau, Wisconsin 54401 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
UMDNJ - New Jersey Medical School | Newark, New Jersey 07103 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Community Health Partners Regional Medical Center | Elyria, Ohio 44035 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Hinsdale Hematology Oncology Associates Incorporated | Hinsdale, Illinois 60521 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Saint Nicholas Hospital | Madison, Wisconsin 53715 |
Alegent Health Lakeside Hospital | Omaha, Nebraska 68130 |
New York Oncology Hematology PC -Albany Medical Center | Albany, New York 12208 |
Central Indiana Cancer Centers - Indianapolis | Indianapolis, Indiana 46227 |
Stanford University Hospitals and Clinics | Stanford, California 94305 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Oncology Associates at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Marie Yeager Cancer Center | Saint Joseph, Michigan 49085 |
Summa Akron City Hospital | Akron, Ohio 44304 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Essentia Health Saint Joseph's Medical Center | Brainerd, Minnesota 56401 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Essentia Health Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
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 |
Essentia Health Cancer Center-South University Clinic | Fargo, North Dakota 58103 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Toledo Clinic Cancer Centers-Bowling Green | Bowling Green, Ohio 43402 |
Toledo Clinic Cancer Centers-Maumee | Maumee, Ohio 43537-1839 |
Toledo Clinic Cancer Centers-Toledo | Toledo, Ohio 43623 |
IU Health Ball Memorial Hospital | Muncie, Indiana 47303 |