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Brief Title: Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Official Title: Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer
Study ID: NCT00826540
Brief Summary: This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, 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. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells
Detailed Description: 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 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 periodically for up to 2 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Saint Anthony Central Hospital, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Exempla Saint Joseph Hospital, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Colorado Cancer Research Program CCOP, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center, Grand Junction, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Galesburg Clinic, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States
Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States
Holy Family Medical Center, Monmouth, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center Foundation, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Pekin Cancer Treatment Center, Pekin, Illinois, United States
Pekin Hospital, Pekin, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Illinois Oncology Research Association CCOP, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Saint Margaret's Hospital, Spring Valley, Illinois, United States
Saint Francis Hospital and Health Centers, Beech Grove, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Community Howard Regional Health, Kokomo, Indiana, United States
Indiana University Health La Porte Hospital, La Porte, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States
Reid Hospital and Health Care Services, Richmond, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
Cedar Rapids Oncology Association, Cedar Rapids, Iowa, United States
Mercy Hospital, Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Mercy Capitol, Des Moines, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Medical Center - North Iowa, Mason City, Iowa, United States
Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Hospital District Sixth of Harper County, Anthony, Kansas, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - 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-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Main Office, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Wichita CCOP, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Bixby Medical Center, Adrian, Michigan, United States
Hickman Cancer Center, Adrian, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan, United States
Oakwood Hospital, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital, Monroe, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Lakeland Hospital, Saint Joseph, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Sanford Clinic North-Bemidgi, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Essentia Health Duluth Clinic CCOP, Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States
Miller-Dwan Hospital, Duluth, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Immanuel-Saint Joseph Hospital-Mayo Health System, Mankato, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro-Minnesota CCOP, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Center for Cancer Care and Research, Saint Louis, Missouri, United States
Saint John's Hospital, Springfield, Missouri, United States
Montana Cancer Consortium CCOP, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies PC, Billings, Montana, United States
Billings Clinic, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Berdeaux, Donald MD (UIA Investigator), Great Falls, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
Northern Montana Hospital, Havre, Montana, United States
Saint Peter's Community Hospital, Helena, Montana, United States
Glacier Oncology PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Hospital, Missoula, Montana, United States
Montana Cancer Specialists, Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Bismarck Cancer Center, Bismarck, North Dakota, United States
Mid Dakota Clinic, Bismarck, North Dakota, United States
Saint Alexius Medical Center, Bismarck, North Dakota, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Clinic North-Fargo, Fargo, North Dakota, United States
Sanford Medical Center-Fargo, Fargo, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, United States
North Coast Cancer Care-Clyde, Clyde, Ohio, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Health Center, Dayton, Ohio, United States
Dayton CCOP, Dayton, Ohio, United States
Hematology Oncology Center Incorporated, Elyria, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Saint Luke's Hospital, Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center, Maumee, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Saint Vincent Mercy Medical Center, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Mercy Cancer Center at Saint Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
Greene Memorial Hospital, Xenia, Ohio, United States
Adventist Medical Center, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazelton, Hazleton, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley, Wilkes-Barre, Pennsylvania, United States
Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States
Midelfort Clinic-Clairemont Campus, Eau Claire, Wisconsin, United States
Mayo Clinic Health System Eau Claire Hospital - Luther Campus, Eau Claire, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Saint Mary's Hospital, Green Bay, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Welch Cancer Center, Sheridan, Wyoming, United States
Name: Axel Grothey, MD
Affiliation: North Central Cancer Treatment Group
Role: STUDY_CHAIR