- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00826540
Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Phase II Study of Sorafenib/Avastin® as Salvage Therapy in Patients With Metastatic Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Colorado
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Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
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Boulder, Colorado, United States, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
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Denver, Colorado, United States, 80210
- Porter Adventist Hospital
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Denver, Colorado, United States, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, United States, 80220
- Rose Medical Center
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Denver, Colorado, United States, 80218
- Exempla Saint Joseph Hospital
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Denver, Colorado, United States, 80224-2522
- Colorado Cancer Research Program CCOP
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Denver, Colorado, United States, 80204
- Saint Anthony Central Hospital
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Englewood, Colorado, United States, 80110
- Swedish Medical Center
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Grand Junction, Colorado, United States, 81502
- Saint Mary's Hospital and Regional Medical Center
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Greeley, Colorado, United States, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, United States, 80501
- Longmont United Hospital
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Loveland, Colorado, United States, 80539
- McKee Medical Center
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Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
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Thornton, Colorado, United States, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, United States, 80033
- Exempla Lutheran Medical Center
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Florida
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Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
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Illinois
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Bloomington, Illinois, United States, 61701
- Saint Joseph Medical Center
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Canton, Illinois, United States, 61520
- Graham Hospital Association
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Carthage, Illinois, United States, 62321
- Memorial Hospital
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Eureka, Illinois, United States, 61530
- Eureka Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Clinic
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Havana, Illinois, United States, 62644
- Mason District Hospital
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Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
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Moline, Illinois, United States, 61265
- Garneau, Stewart C MD (UIA Investigator)
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Moline, Illinois, United States, 61265
- Porubcin, Michael MD (UIA Investigator)
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Moline, Illinois, United States, 61265
- Sharis, Christine M MD (UIA Investigator)
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Moline, Illinois, United States, 61265
- Stoffel, Thomas J MD (UIA Investigator)
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Monmouth, Illinois, United States, 61462
- Holy Family Medical Center
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Normal, Illinois, United States, 61761
- Community Cancer Center Foundation
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Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
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Ottawa, Illinois, United States, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, United States, 61350
- Ottawa Regional Hospital and Healthcare Center
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Pekin, Illinois, United States, 61554
- Pekin Cancer Treatment Center
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Pekin, Illinois, United States, 61554
- Pekin Hospital
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Peoria, Illinois, United States, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, United States, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, United States, 61614
- Proctor Hospital
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Peoria, Illinois, United States, 61603
- Methodist Medical Center of Illinois
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Peoria, Illinois, United States, 61615
- Illinois Oncology Research Association CCOP
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Peru, Illinois, United States, 61354
- Illinois Valley Hospital
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Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, United States, 61362
- Saint Margaret's Hospital
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Indiana
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Beech Grove, Indiana, United States, 46107
- Saint Francis Hospital and Health Centers
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
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Kokomo, Indiana, United States, 46904
- Community Howard Regional Health
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La Porte, Indiana, United States, 46350
- Indiana University Health La Porte Hospital
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Mishawaka, Indiana, United States, 46545-1470
- Saint Joseph Regional Medical Center-Mishawaka
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Richmond, Indiana, United States, 47374
- Reid Hospital and Health Care Services
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South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, United States, 46617
- South Bend Clinic
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South Bend, Indiana, United States, 46601
- Northern Indiana Cancer Research Consortium
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Iowa
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Bettendorf, Iowa, United States, 52722
- Constantinou, Costas L MD (UIA Investigator)
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Cedar Rapids, Iowa, United States, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, United States, 52403
- Oncology Associates at Mercy Medical Center
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Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Association
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Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
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Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates-Des Moines
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Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, United States, 50307
- Mercy Capitol
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Des Moines, Iowa, United States, 50309
- Iowa Oncology Research Association CCOP
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Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates
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Mason City, Iowa, United States, 50401
- Mercy Medical Center - North Iowa
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Sioux City, Iowa, United States, 51104
- Saint Luke's Regional Medical Center
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology Oncology Associates
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Sioux City, Iowa, United States, 51104
- Mercy Medical Center-Sioux City
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Kansas
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Anthony, Kansas, United States, 67003
- Hospital District Sixth of Harper County
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, United States, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
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Newton, Kansas, United States, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, United States, 67357
- Cancer Center of Kansas - Parsons
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Pratt, Kansas, United States, 67124
- Cancer Center of Kansas - Pratt
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Salina, Kansas, United States, 67401
- Cancer Center of Kansas - Salina
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Wellington, Kansas, United States, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
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Wichita, Kansas, United States, 67208
- Associates In Womens Health
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas - Main Office
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Wichita, Kansas, United States, 67214
- Via Christi Regional Medical Center
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Wichita, Kansas, United States, 67214
- Wichita CCOP
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Winfield, Kansas, United States, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, United States, 49221
- Bixby Medical Center
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Adrian, Michigan, United States, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Hospital
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Ann Arbor, Michigan, United States, 48106
- Michigan Cancer Research Consortium Community Clinical Oncology Program
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Dearborn, Michigan, United States, 48124
- Oakwood Hospital
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Detroit, Michigan, United States, 48236
- Saint John Hospital and Medical Center
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Escanaba, Michigan, United States, 49431
- Green Bay Oncology - Escanaba
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Flint, Michigan, United States, 48502
- Hurley Medical Center
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Flint, Michigan, United States, 48532
- Genesys Regional Medical Center-West Flint Campus
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Iron Mountain, Michigan, United States, 49801
- Green Bay Oncology - Iron Mountain
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Jackson, Michigan, United States, 49201
- Allegiance Health
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Lansing, Michigan, United States, 48912
- Sparrow Hospital
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Livonia, Michigan, United States, 48154
- Saint Mary Mercy Hospital
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Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
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Pontiac, Michigan, United States, 48341-2985
- Saint Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Saint Joseph Mercy Port Huron
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Saginaw, Michigan, United States, 48601
- Saint Mary's of Michigan
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Saint Joseph, Michigan, United States, 49085
- Lakeland Hospital
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Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
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Minnesota
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Bemidji, Minnesota, United States, 56601
- Sanford Clinic North-Bemidgi
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
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Duluth, Minnesota, United States, 55805
- Essentia Health Saint Mary's Medical Center
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Duluth, Minnesota, United States, 55805
- Miller-Dwan Hospital
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Duluth, Minnesota, United States, 55805
- Essentia Health Duluth Clinic CCOP
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Edina, Minnesota, United States, 55435
- Fairview-Southdale Hospital
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Fridley, Minnesota, United States, 55432
- Unity Hospital
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Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
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Mankato, Minnesota, United States, 56002
- Immanuel-Saint Joseph Hospital-Mayo Health System
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Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute
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Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, United States, 55416
- Metro-Minnesota CCOP
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Saint Paul, Minnesota, United States, 55101
- Regions Hospital
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Saint Paul, Minnesota, United States, 55102
- United Hospital
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Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology and Hematology PA-Woodbury
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Missouri
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, United States, 63141
- Center for Cancer Care and Research
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Springfield, Missouri, United States, 65804
- Saint John's Hospital
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Montana
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Billings, Montana, United States, 59101
- Saint Vincent Healthcare
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Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, United States, 59101
- Montana Cancer Consortium CCOP
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Billings, Montana, United States, 59102
- Hematology-Oncology Centers of the Northern Rockies PC
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Billings, Montana, United States, 59107-7000
- Billings Clinic
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Bozeman, Montana, United States, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
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Great Falls, Montana, United States, 59405
- Great Falls Clinic
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Great Falls, Montana, United States, 59405
- Berdeaux, Donald MD (UIA Investigator)
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Havre, Montana, United States, 59501
- Northern Montana Hospital
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Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, United States, 59901
- Glacier Oncology PLLC
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Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology
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Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, United States, 59801
- Community Medical Hospital
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Missoula, Montana, United States, 59802
- Montana Cancer Specialists
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Sanford Bismarck Medical Center
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Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic
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Bismarck, North Dakota, United States, 58501
- Saint Alexius Medical Center
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Fargo, North Dakota, United States, 58122
- Sanford Clinic North-Fargo
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Fargo, North Dakota, United States, 58122
- Sanford Medical Center-Fargo
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Grand Forks, North Dakota, United States, 58201
- Altru Cancer Center
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Ohio
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Bowling Green, Ohio, United States, 43402
- Toledo Clinic Cancer Centers-Bowling Green
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Clyde, Ohio, United States, 43410
- North Coast Cancer Care-Clyde
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Dayton, Ohio, United States, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, United States, 45409
- Miami Valley Hospital
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Dayton, Ohio, United States, 45415
- Samaritan North Health Center
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Dayton, Ohio, United States, 45405
- Grandview Hospital
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Dayton, Ohio, United States, 45420
- Dayton CCOP
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Elyria, Ohio, United States, 44035
- Hematology Oncology Center Incorporated
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Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
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Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, United States, 45331
- Wayne Hospital
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Kettering, Ohio, United States, 45429
- Kettering Medical Center
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Lima, Ohio, United States, 45804
- Lima Memorial Hospital
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Maumee, Ohio, United States, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
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Maumee, Ohio, United States, 43537
- Saint Luke's Hospital
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Maumee, Ohio, United States, 43537-1839
- Toledo Clinic Cancer Centers-Maumee
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Oregon, Ohio, United States, 43616
- Saint Charles Hospital
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Oregon, Ohio, United States, 43616
- Toledo Clinic Cancer Centers-Oregon
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Sandusky, Ohio, United States, 44870
- North Coast Cancer Care
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Sylvania, Ohio, United States, 43560
- Flower Hospital
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Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, United States, 43608
- Saint Vincent Mercy Medical Center
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Toledo, Ohio, United States, 43623
- Toledo Clinic Cancer Centers-Toledo
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Toledo, Ohio, United States, 43614
- University of Toledo
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Toledo, Ohio, United States, 43617
- Toledo Community Hospital Oncology Program CCOP
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Toledo, Ohio, United States, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Toledo, Ohio, United States, 43623
- Mercy Cancer Center at Saint Anne Mercy Hospital
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Troy, Ohio, United States, 45373
- Upper Valley Medical Center
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Wauseon, Ohio, United States, 43567
- Fulton County Health Center
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Wilmington, Ohio, United States, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, United States, 45385
- Greene Memorial Hospital
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Oregon
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Portland, Oregon, United States, 97216
- Adventist Medical Center
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-2001
- Geisinger Medical Center
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Hazleton, Pennsylvania, United States, 18201
- Geisinger Medical Center-Cancer Center Hazelton
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State College, Pennsylvania, United States, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley
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Virginia
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Fredericksburg, Virginia, United States, 22401
- Fredericksburg Oncology Inc
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Wisconsin
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Eau Claire, Wisconsin, United States, 54702
- Midelfort Clinic-Clairemont Campus
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Eau Claire, Wisconsin, United States, 54703
- Mayo Clinic Health System Eau Claire Hospital - Luther Campus
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Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital
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Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology Limited at Saint Mary's Hospital
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Green Bay, Wisconsin, United States, 54303
- Saint Mary's Hospital
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Green Bay, Wisconsin, United States, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
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Manitowoc, Wisconsin, United States, 54221
- Holy Family Memorial Hospital
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Marinette, Wisconsin, United States, 54143
- Bay Area Medical Center
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Oconto Falls, Wisconsin, United States, 54154
- Green Bay Oncology - Oconto Falls
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Sturgeon Bay, Wisconsin, United States, 54235
- Green Bay Oncology - Sturgeon Bay
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Wyoming
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Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of stage IV colorectal cancer (histologic proof is not required)
Measurable disease
- Spiral CT scan required for both pre- and post-treatment tumor assessments of lesions measuring 1-2 cm
- Progressive disease during or within 6 months of most recent prior chemotherapy regimen (bevacizumab, fluoropyrimidine, oxaliplatin, or irinotecan-based treatment) OR considered ineligible for standard therapy
- Documentation of submission of tumor material for Kirsten Rat Sarcoma (KRAS) testing available
- Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab or panitumumab) required for patients with wild-type KRAS tumor
No known brain metastasis
- Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy ≥ 6 months
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- White blood cell count (WBC) ≥ 3,400/mm³
- International normalized ratio (INR) < 1.5 (≤ 3.0 if on anti-coagulation therapy [e.g., warfarin or heparin])
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if there is liver involvement)
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Urine protein:creatinine ratio < 1 OR urine dipstick < 2+ OR urine protein < 1,000 mg by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment (≥ 2 weeks after completion of treatment with sorafenib tosylate alone)
- Willing to provide mandatory blood samples for translational research studies
- Able to swallow whole pills
- No inadequately controlled hypertension (i.e., systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg on anti-hypertensive medications)
- No prior hypertensive crisis or hypertensive encephalopathy
- No myocardial infarction or unstable angina within the past 6 months
- No congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
- No hemorrhage or bleeding event > grade 3 within the past 4 weeks
- No evidence or history of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- No greater than normal risk of bleeding
- No active or recent hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia requiring anti-arrhythmic drugs
- Psychiatric illness or social situations that would limit compliance with study requirements
- No known HIV infection or chronic hepatitis B or C infection
No serious, non-healing wound, active ulcer, or untreated bone fracture
- Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy
- No significant traumatic injury within the past 4 weeks
- No known or suspected allergy or hypersensitivity to any component of bevacizumab, sorafenib tosylate, or their excipients or to any other agent given in the course of this study
- No malabsorption problem
None of the following within the past 6 months:
- Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
- Peripheral arterial thrombosis
- Symptomatic peripheral vascular disease
- Abdominal fistula
- Gastrointestinal perforation
- Intra-abdominal abscess
No other active malignancy within the past 3 years except non melanoma skin cancer or carcinoma in situ of the cervix
- Prior malignancy allowed provided patient is not receiving other specific treatment for that malignancy (other than hormonal therapy)
- No other concurrent investigational agent for this cancer
- Prior radiotherapy allowed
- No prior sorafenib tosylate
- No prior discontinuation of bevacizumab due to adverse events
- More than 4 weeks since prior and no concurrent participation in any other experimental drug study
- More than 4 weeks since prior St. John's wort or rifampin
- More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
- More than 7 days since prior core biopsy or minor surgical procedure, including placement of a vascular access device
- No concurrent anticoagulant, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (sorafenib tosylate and bevacizumab)
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
|
Given IV
Other Names:
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival Rate
Time Frame: At 3 months
|
The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. |
At 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: Up to 2 years
|
Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers.
Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.
|
Up to 2 years
|
Overall Survival
Time Frame: Time from registration to death, assessed up to 2 years
|
The distribution of overall survival will be estimated using Kaplan-Meier methodology.
|
Time from registration to death, assessed up to 2 years
|
Feasibility of Study Treatment
Time Frame: Up to 2 years
|
Will be evaluated based on the number of patients who are able to> tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.
|
Up to 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Axel Grothey, MD, North Central Cancer Treatment Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Recurrence
- Rectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Antibodies
- Sorafenib
- Immunoglobulins
- Bevacizumab
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- NCCTG-N054C
- U10CA025224 (U.S. NIH Grant/Contract)
- NCI-2009-01177 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000632342 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage IV Colon Cancer
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University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Adenocarcinoma | Advanced Colon Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage III Colon Cancer | Stage III Rectal CancerUnited States
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC... and other conditionsUnited States
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Howard S. Hochster, MDRecruitingStage IV Colon Cancer AJCC v8 | Stage IVA Colon Cancer AJCC v8 | Stage IVB Colon Cancer AJCC v8 | Stage IVC Colon Cancer AJCC v8 | Metastatic Colon CarcinomaUnited States
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M.D. Anderson Cancer CenterBristol-Myers Squibb; Syntrix Biosystems, Inc.RecruitingMetastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC... and other conditionsUnited States
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National Cancer Institute (NCI)TerminatedColorectal Carcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Colorectal Carcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 and other conditionsUnited States
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Ohio State University Comprehensive Cancer CenterCompletedRecurrent Colon Cancer | Recurrent Rectal Cancer | Stage IV A Bladder Cancer | Stage IV A Rectal Cancer | Stage IV B Colon Cancer | Stage IV B Rectal CancerUnited States
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)TerminatedMetastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Colon Cancer AJCC... and other conditionsUnited States
Clinical Trials on bevacizumab
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National Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditionsUnited States
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National Cancer Institute (NCI)NRG OncologyCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain NeoplasmUnited States, Canada
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M.D. Anderson Cancer CenterRecruitingStage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8United States
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National Cancer Institute (NCI)Active, not recruitingOvarian Endometrioid Adenocarcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Ovarian High Grade Serous Adenocarcinoma | Platinum-Resistant... and other conditionsUnited States, Canada
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | Fallopian Tube... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7United States
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Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditionsUnited States
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National Cancer Institute (NCI)Active, not recruitingStage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable MelanomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditionsUnited States