Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer
PRIMARY OBJECTIVES:
I. Evaluate proportion of patients who are progression-free at 3 months (in historic
comparison with results for single-agent bevacizumab in ECOG 3200).
SECONDARY OBJECTIVES:
I. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility
TERTIARY OBJECTIVES:
I. To determine the relationship between tumor biomarkers and circulating biomarkers of
vascular response and clinical outcome in metastatic colorectal cancer patients treated with
the sorafenib/bevacizumab combination.
II. As part of ongoing research for NCCTG GI studies, we are banking leftover tissue and
blood products (i.e., plasma, DNA, and buffy coat) for future studies.
OUTLINE: This is a multicenter study.
Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab
IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease
progression or unacceptable toxicity. Blood samples are collected at baseline and then
periodically during study treatment for laboratory biomarker and pharmacogenetic studies.
After completion of study treatment, patients are followed up periodically for up to 2
years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
At 3 months
No
Axel Grothey
Principal Investigator
North Central Cancer Treatment Group
United States: Food and Drug Administration
NCI-2009-01177
NCT00826540
September 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
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 |
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 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Great Falls Clinic | Great Falls, Montana 59405 |
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 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
South Bend Clinic | South Bend, Indiana 46617 |
Memorial Hospital | Carthage, Illinois 62321 |
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 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Grandview Hospital | Dayton, Ohio 45405 |
Lima Memorial Hospital | Lima, Ohio 45804 |
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 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Pekin Hospital | Pekin, Illinois 61554 |
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 |
Altru Cancer Center | Grand Forks, North Dakota 58206 |
Saint Luke's Hospital | Maumee, Ohio 43537 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Center for Cancer Care and Research | St. Louis, Missouri 63141 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Hospital District Sixth of Harper County | Anthony, Kansas 67003 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Northern Montana Hospital | Havre, Montana 59501 |
Wayne Hospital | Greenville, Ohio 45331 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
Adventist Medical Center | Portland, Oregon 97216 |
Longmont United Hospital | Longmont, Colorado 80501 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Mid Dakota Clinic | Bismarck, North Dakota 58501 |
Presbyterian - Saint Lukes Medical Center - Health One | Denver, Colorado 80218 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
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 |
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 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
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 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 |
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 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
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 |
Immanuel-Saint Joseph Hospital-Mayo Health System | Mankato, Minnesota 56002 |
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 |
Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
Saint John's Hospital | Springfield, Missouri 65804 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Saint Alexius Medical Center | Bismarck, North Dakota 58501 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
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 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Mayo Clinic Health System Eau Claire Hospital - Luther Campus | Eau Claire, Wisconsin 54703 |
Midelfort Clinic-Clairemont Campus | Eau Claire, Wisconsin 54702 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Oncology Associates at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Sanford Clinic North-Fargo | Fargo, North Dakota 58102 |
Sanford Medical Center-Fargo | Fargo, North Dakota 58122 |
The Toledo Hospital/Toledo Children's Hospital | Toledo, Ohio 43606 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Sanford Clinic North-Bemidgi | Bemidji, Minnesota 56601 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Essentia Health Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Sanford Bismarck Medical Center | Bismarck, North Dakota 58501 |
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 |
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 |