Spots Global Cancer Trial Database for Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy
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Trial Identification
Brief Title: Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy
Official Title: 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
Study ID: NCT01079780
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
Detailed Description: 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 survival 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 A: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride over 60-90 minutes on day 1. * Arm B: Patients receive ramucirumab IV over 60 minutes on day 1 and cetuximab and irinotecan hydrochloride as in arm A. Arm B was closed early due to excessive toxicities and Arm C was then added to the study with reduced dose of protocol drugs. * Arm C: Patients receive reduced dose of ramucirumab, cetuximab and irinotecan hydrochloride as in arm B. In all 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
St. Anthony Central Hospital, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Front Range Cancer Specialists, Fort Collins, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Yale Cancer Center, New Haven, Connecticut, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler, Savannah, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Kellogg Cancer Care Center, Highland Park, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Provena St. Mary's Regional Cancer Center - Kankakee, Kankakee, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
Swedish-American Regional Cancer Center, Rockford, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
William N. Wishard Memorial Hospital, Indianapolis, Indiana, United States
Clarian Arnett Cancer Care, Lafayette, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
McFarland Clinic, PC, Ames, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States
Cancer Center of Kansas, PA - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
Ochsner Health Center - Bluebonnet, Baton Rouge, Louisiana, United States
Ochsner Health Center - Covington, Covington, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Greater Baltimore Medical Center Cancer Center, Baltimore, Maryland, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller - Dwan Medical Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology - Woodbury, Woodbury, Minnesota, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha, Nebraska, United States
Lakeside Hospital, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey, United States
CentraState Medical Center, Freehold, New Jersey, United States
Hematology Oncology Associates, PC, Albuquerque, New Mexico, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
New Mexico Cancer Care Associates, Santa Fe, New Mexico, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
Roger Maris Cancer Center at MeritCare Hospital, Fargo, North Dakota, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Medical Center Cancer Care, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Community Cancer Center, Elyria, Ohio, United States
Hematology Oncology Center, Elyria, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
St. Rita's Medical Center, Lima, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Northwest Ohio Oncology Center, Maumee, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Toledo Clinic - Oregon, Oregon, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
St. Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Doylestown Hospital Cancer Center, Doylestown, Pennsylvania, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital, Harrisburg, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center, Pottstown, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Hematology and Oncology Associates of Northeastern Pennsylvania, Scranton, Pennsylvania, United States
Grand View Hospital, Sellersville, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Chester County Hospital, West Chester, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
CCOP - Main Line Health, Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Parkland Memorial Hospital, Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States
West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia, United States
Langlade Memorial Hospital, Antigo, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Vince Lombardi Cancer Clinic - Marinette, Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, United States
St. Nicholas Hospital, Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic - Sheboygan, Sheboygan, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Aurora Medical Center, Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic - Two Rivers, Two Rivers, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Riverview UW Cancer Center at Riverview Hospital, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Howard S. Hochster, MD
Affiliation: NYU Langone Health
Role: PRINCIPAL_INVESTIGATOR
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