A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMCA12 for Patients With Extensive Stage Small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. To evaluate the progression-free survival of patients with extensive stage small cell
lung cancer treated with cisplatin and etoposide with or without Hedgehog antagonist
GDC-0449 or cixutumumab.
SECONDARY OBJECTIVES:
I. To evaluate the response rate in patients treated with these regimens. II. To evaluate
the overall survival of patients treated with these regimens. III. To evaluate the toxicity
of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to gender. Patients
are randomized to 1 of 3 treatment arms.
ARM I: Patients receive cisplatin IV over 1-2 hours on day 1 and etoposide phosphate IV over
1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.
ARM II: Patients receive cisplatin and etoposide phosphate as in arm I and oral Hedgehog
antagonist GDC-0449 once daily on days 1-21. Treatment repeats every 21 days for 4 courses
in the absence of disease progression or unacceptable toxicity. Patients then receive
Hedgehog antagonist GDC-0449 alone once daily in the absence of disease progression or
unacceptable toxicity.
ARM III: Patients receive cisplatin and etoposide phosphate as in arm I and cixutumumab IV
over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab
alone once weekly 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 1 year.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Time from randomization to death or disease progression, whichever occurs first, assessed up to 3 years
No
Chandra Belani
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2011-01917
NCT00887159
July 2009
Name | Location |
---|---|
Albert Einstein College of Medicine | Bronx, New York 10461 |
Johns Hopkins University | Baltimore, Maryland 21205 |
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 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Stanford University | Stanford, California 94305 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
York Hospital | York, Pennsylvania 17315 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
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 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
Memorial Hospital | Carthage, Illinois 62321 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
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 |
MeritCare Medical Group | Fargo, North Dakota 58122 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
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 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Hematology Oncology Associates of Illinois-Highland Park | Highland Park, Illinois 60035 |
Trinity Medical Center | Moline, Illinois 61265-1291 |
Pekin Hospital | Pekin, Illinois 61554 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Ottumwa Regional Health Center | Ottumwa, Iowa 52501 |
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 |
Lancaster General Hospital | Lancaster, Pennsylvania 17604-3555 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Fisher-Titus Medical Center | Norwalk, Ohio 44857 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Longmont United Hospital | Longmont, Colorado 80501 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Memorial Medical Center | Springfield, Illinois 62781 |
University of Virginia | Charlottesville, Virginia 22908 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
Northwestern University | Chicago, Illinois 60611 |
Elmhurst Memorial Hospital | Elmhurst, Illinois 60126 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Case Western Reserve University | Cleveland, Ohio 44106 |
Emory University | Atlanta, Georgia 30322 |
Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
Toledo Clinic | Oregon, Ohio 43616 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
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 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
Butler Memorial Hospital | Butler, Pennsylvania 16001 |
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 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Veterans Administration Medical Center | Decatur, Georgia 30033 |
Saint Joseph's-Candler Health System | Savannah, Georgia 31405 |
John H Stroger Jr Hospital of Cook County | Chicago, Illinois 60612-3785 |
Evanston CCOP-NorthShore University HealthSystem | Evanston, Illinois 60201 |
Provena Saint Mary's Hospital | Kankakee, Illinois 60901 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
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 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
McFarland Clinic | Ames, Iowa 50010 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Capitol | Des Moines, Iowa 50307 |
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 |
Siouxland Hematology - Oncology Associates | Sioux City, Iowa 51101 |
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 |
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 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Merit Care Clinic Bemidji | Bemidji, Minnesota 56601 |
Saint Mary's Medical Center | Duluth, Minnesota 55805 |
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 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Hunterdon Medical Center | Flemington, New Jersey 08822 |
Sparta Cancer Treatment Center | Sparta, New Jersey 07871 |
New York University Langone Medical Center | New York, New York 10016 |
Dickstein Cancer Treatment Center | White Plains, New York 10601 |
Meritcare Hospital | Fargo, North Dakota 58122 |
Aultman Health Foundation | Canton, Ohio 44710 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee, Ohio 43537 |
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 |
The Toledo Hospital | Toledo, Ohio 43606 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Ephrata Cancer Center | Ephrata, Pennsylvania 17522 |
Hematology and Oncology Associates of North East Pennsylvania | Scranton, Pennsylvania 18508 |
Scranton Hematology Oncology | Scranton, Pennsylvania 18510 |
Mercy Hospital | Scranton, Pennsylvania 18501 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center-Oncology Clinic | Sioux Falls, South Dakota 57104 |
Sanford University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Dean Hematology and Oncology Clinic | Madison, Wisconsin 53717 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Illinois CancerCare-Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare-Canton | Canton, Illinois 61520 |
Illinois CancerCare-Carthage | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka | Eureka, Illinois 61530 |
Illinois CancerCare-Havana | Havana, Illinois 62644 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare-Macomb | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare-Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare-Pekin | Pekin, Illinois 61603 |
Illinois CancerCare-Peru | Peru, Illinois 61354 |
Illinois CancerCare-Princeton | Princeton, Illinois 61356 |
Illinois CancerCare-Spring Valley | Spring Valley, Illinois 61362 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Hackensack University Medical CCOP | Hackensack, New Jersey 07601 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Community Health Partners Regional Medical Center | Elyria, Ohio 44035 |
Saint Mary Medical and Regional Cancer Center | Langhorne, Pennsylvania 19047 |
Vanderbilt-Ingram Cancer Center Cool Springs | Franklin, Tennessee 37067 |
West Virginia University Charleston | Charleston, West Virginia 25304 |
Marshfield Clinic-Chippewa Center | Chippewa Falls, Wisconsin 54729 |
Medical Consultants Limited | Milwaukee, Wisconsin 53215 |
Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Spector, David MD (UIA Investigator) | Moline, Illinois 61265 |
Doctors Carrol, Sheth, Raghavan | Louisville, Kentucky 40215 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
New York Oncology Hematology PC -Albany Medical Center | Albany, New York 12208 |
New York Oncology Hematology PC - Albany | Albany, New York 12206 |
New York Oncology Hematology PC - Amsterdam | Amsterdam, New York 12010 |
New York Oncology Hematology PC-Hudson | Hudson, New York 12534 |
New York Oncology Hematology PC - Latham | Latham, New York 12110 |
New York Oncology Hematology PC - Rexford | Rexford, New York 12148 |
New York Oncology Hematology PC - Troy | Troy, New York 12180 |
Boca Raton Regional Hospital | Boca Raton, Florida 33486 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
Lake Region Healthcare Corporation-Cancer Care | Fergus Falls, Minnesota 56537 |
Guthrie Clinic-Robert Packer Hospital | Sayre, Pennsylvania 18840 |
Blue Ridge Medical Specialists PC | Bristol, Tennessee 37620 |