A Randomized Phase II Study of Irinotecan and Cetuximab With or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy
OBJECTIVES:
- To evaluate the progression-free survival of patients with advanced K-ras wild-type
colorectal cancer, following progression on bevacizumab-contained chemotherapy, treated
with irinotecan hydrochloride and cetuximab with versus without ramucirumab as
second-line therapy.
- To evaluate the response rate in patients treated with these regimens.
- To evaluate the grade 3-4 toxicity rates of these regimens in these patients.
- To evaluate the overall suvival of patients treated with these regimens.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
performance status (0 vs 1), discontinuation of oxaliplatin before disease progression (yes
vs no), and time to disease progression since last treatment (≤ 6 months vs > 6 months).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride
over 60-90 minutes on day 1.
- Arm II: Patients receive ramucirumab IV over 60 minutes on day 1 and cetuximab and
irinotecan hydrochloride as in arm I.
In both arms, courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients are followed up periodically for 5 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
No
Howard S. Hochster, MD
Principal Investigator
New York University School of Medicine
United States: Federal Government
CDR0000666736
NCT01079780
November 2010
Name | Location |
---|---|
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Columbus | Columbus, Ohio 43206 |
Grand View Hospital | Sellersville, Pennsylvania 18960 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
Toledo Hospital | Toledo, Ohio 43606 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Chester County Hospital | West Chester, Pennsylvania 19380 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Mason District Hospital | Havana, Illinois 62644 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Medical Center of Louisiana - New Orleans | New Orleans, Louisiana 70112 |
Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
St. Charles Mercy Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Holy Family Memorial Medical Center Cancer Care Center | Manitowoc, Wisconsin 54221-1450 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
Kellogg Cancer Care Center | Highland Park, Illinois 60035 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
William N. Wishard Memorial Hospital | Indianapolis, Indiana 46202 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Ochsner Health Center - Bluebonnet | Baton Rouge, Louisiana 70809 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Hematology Oncology Center | Elyria, Ohio 44035 |
Community Cancer Center | Elyria, Ohio 44035 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
St. Anne Mercy Hospital | Toledo, Ohio 43623 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay, Wisconsin 54311 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Vince Lombardi Cancer Clinic - Marinette | Marinette, Wisconsin 54143 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan, Wisconsin 53081 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Aurora Medical Center | Summit, Wisconsin 53066 |
Vince Lombardi Cancer Clinic - Two Rivers | Two Rivers, Wisconsin 54241 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Diagnostic and Treatment Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
New Mexico Cancer Care Associates | Santa Fe, New Mexico 87505-7670 |
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Hematology Oncology Associates, PC | Albuquerque, New Mexico 87106 |
Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee, Illinois 60901 |
Ochsner Health Center - Covington | Covington, Louisiana 70433 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
CentraState Medical Center | Freehold, New Jersey 07728 |
Clarian Arnett Cancer Care | Lafayette, Indiana 47904 |
Langlade Memorial Hospital | Antigo, Wisconsin 54409 |
Lakeside Hospital | Omaha, Nebraska 68130 |
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | Albuquerque, New Mexico 87110 |
Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
St. Nicholas Hospital | Sheboygan, Wisconsin 53081 |
Doylestown Hospital Cancer Center | Doylestown, Pennsylvania 18901 |
Cancer Center of Kansas, PA - McPherson | McPherson, Kansas 67460 |