Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
23 de marzo de 2022 actualizado por: Alliance for Clinical Trials in Oncology
Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
RATIONALE: 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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of bevacizumab in combination with sorafenib tosylate in patients with locally advanced or metastatic hepatocellular carcinoma. (Phase I closed to accrual as of 11/03/2010)
- Determine time to progression in these patients. (Phase II)
Secondary
- Determine the safety of this regimen in these patients. (Phase I closed to accrual as of 11/03/2010)
- Assess tolerability of this regimen in these patients. (Phase I closed to accrual as of 11/03/2010)
- Determine overall survival of these patients. (Phase II)
- Determine tumor response (at 6 months) in patients treated with this regimen. (Phase II)
- Determine progression-free survival of these patients. (Phase II)
- Determine response rate in patients treated with this regimen. (Phase II)
- Assess the occurrence of adverse events in these patients. (Phase II)
Tertiary
- Determine the relationship between tumor biomarkers and circulating biomarkers of vascular response and clinical outcome in patients treated with this regimen.
OUTLINE: This is a phase I, dose escalation study followed by a randomized phase II study.
- Phase I (closed to accrual as of 11/03/2010): Patients receive oral sorafenib tosylate twice daily on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients are stratified according to gender (female vs male), ECOG performance status (0 vs 1), and Child-Pugh class (A vs B7). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for analysis of circulating endothelial cells and circulating endothelial progenitor cells and angiogenic proteins in plasma by ELISA.
After completion of study treatment, patients are followed for 3 years.
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Aurora, Colorado, Estados Unidos, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Estados Unidos, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Estados Unidos, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Estados Unidos, 80210
- Porter Adventist Hospital
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Denver, Colorado, Estados Unidos, 80220
- Rose Medical Center
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Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Estados Unidos, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Estados Unidos, 80218
- St. Joseph Hospital
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Denver, Colorado, Estados Unidos, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Estados Unidos, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Estados Unidos, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Estados Unidos, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Estados Unidos, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Estados Unidos, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Estados Unidos, 80539
- McKee Medical Center
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Pueblo, Colorado, Estados Unidos, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Estados Unidos, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Estados Unidos, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Illinois
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Bloomington, Illinois, Estados Unidos, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Estados Unidos, 61701
- St. Joseph Medical Center
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Canton, Illinois, Estados Unidos, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Estados Unidos, 61520
- Graham Hospital
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Carthage, Illinois, Estados Unidos, 62321
- Memorial Hospital
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Carthage, Illinois, Estados Unidos, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Estados Unidos, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Estados Unidos, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Estados Unidos, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Estados Unidos, 62644
- Mason District Hospital
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Havana, Illinois, Estados Unidos, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Estados Unidos, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Estados Unidos, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Estados Unidos, 61455
- Mcdonough District Hospital
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Moline, Illinois, Estados Unidos, 61265
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Moline, Illinois, Estados Unidos, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Estados Unidos, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Estados Unidos, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Estados Unidos, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Estados Unidos, 61761
- Community Cancer Center
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Normal, Illinois, Estados Unidos, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Estados Unidos, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Estados Unidos, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Estados Unidos, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Estados Unidos, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Estados Unidos, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Estados Unidos, 61614
- Proctor Hospital
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Peoria, Illinois, Estados Unidos, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Estados Unidos, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Estados Unidos, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Estados Unidos, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Estados Unidos, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Estados Unidos, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Estados Unidos, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Estados Unidos, 61362
- Illinois CancerCare - Spring Valley
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Iowa
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Bettendorf, Iowa, Estados Unidos, 52722
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Clive, Iowa, Estados Unidos, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Estados Unidos, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Estados Unidos, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Estados Unidos, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Estados Unidos, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Estados Unidos, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Estados Unidos, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Estados Unidos, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Estados Unidos, 67905
- Cancer Center of Kansas, PA - Liberal
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Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Estados Unidos, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Estados Unidos, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- CCOP - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Estados Unidos, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Estados Unidos, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Estados Unidos, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Estados Unidos, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Estados Unidos, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Estados Unidos, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Estados Unidos, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Estados Unidos, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Estados Unidos, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Estados Unidos, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Estados Unidos, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Estados Unidos, 48154
- St. Mary Mercy Hospital
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Muskegon, Michigan, Estados Unidos, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Estados Unidos, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Estados Unidos, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Estados Unidos, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Traverse City, Michigan, Estados Unidos, 49684
- Munson Medical Center
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Warren, Michigan, Estados Unidos, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Estados Unidos, 49519
- Metro Health Hospital
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Minnesota
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Bemidji, Minnesota, Estados Unidos, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Duluth, Minnesota, Estados Unidos, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Estados Unidos, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Estados Unidos, 56537
- Fergus Falls Medical Group, PA
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Fridley, Minnesota, Estados Unidos, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Estados Unidos, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Estados Unidos, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Estados Unidos, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Estados Unidos, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Estados Unidos, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Estados Unidos, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Stillwater, Minnesota, Estados Unidos, 55082
- Lakeview Hospital
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Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Estados Unidos, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Missouri
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Jefferson City, Missouri, Estados Unidos, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Estados Unidos, 63141
- Comprehensive Cancer Care, PC
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Montana
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Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Estados Unidos, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Estados Unidos, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Estados Unidos, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Estados Unidos, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Estados Unidos, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Estados Unidos, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Estados Unidos, 59501
- Northern Montana Hospital
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Helena, Montana, Estados Unidos, 59601
- St. Peter's Hospital
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Kalispell, Montana, Estados Unidos, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Estados Unidos, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Estados Unidos, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Estados Unidos, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Estados Unidos, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Estados Unidos, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Broadway
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Estados Unidos, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Estados Unidos, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Estados Unidos, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Estados Unidos, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Estados Unidos, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Estados Unidos, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Estados Unidos, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Manitowoc, Wisconsin, Estados Unidos, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Estados Unidos, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, Estados Unidos, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sheboygan, Wisconsin, Estados Unidos, 53081
- St. Nicholas Hospital
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Sturgeon Bay, Wisconsin, Estados Unidos, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wyoming
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Casper, Wyoming, Estados Unidos, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, Estados Unidos, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 120 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular carcinoma
- Locally advanced or metastatic disease that is not amenable to treatment with surgery or to orthotopic liver transplant
- Child Pugh class A or B7 disease
- Measurable disease
- No mixed cholangiocarcinoma/hepatocellular carcinoma
- No current or previously resected brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,200/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Urine protein ≤ 1+ by urine protein:creatinine ratio OR 24-hour urine protein < 1 g
- QTc interval ≤ 500 msec on baseline EKG
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 2 weeks after sorafenib tosylate and 6 months after bevacizumab
None of the following risk factors for decreased LVEF:
- Prior treatment with anthracyclines
- History of myocardial infarction within the past 12 months
- No uncontrolled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management
- No New York Heart Association class III-IV congestive heart failure
- No cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- No history of hypertensive crisis or hypertensive encephalopathy
- No cardiac ventricular arrhythmia requiring anti-arrhythmic therapy within the past 6 months
None of the following within the past 6 months:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina or angina
- Clinically significant peripheral artery disease (i.e., claudication in less than one block) or any other arterial thrombotic event
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis
- No active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
- No evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)
- No significant traumatic injury within the past 4 weeks
- No serious or non-healing wound, ulcer, or bone fracture
- No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- No other active malignancy within the past 3 years, except nonmelanotic skin cancer or carcinoma in situ of the cervix
- No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or sorafenib tosylate
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy regimens for hepatocellular carcinoma
- No prior external beam radiation to the primary site
- No prior central thoracic radiation therapy (RT), including RT to the heart
- No prior radiation (if given for another malignancy) to ≥ 25% of the bone marrow
- At least 6 weeks since prior chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies
- More than 4 weeks since prior biologic, hormonal, or immune therapy
- More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
- More than 7 days since prior core biopsy or other minor surgical procedure (placement of a vascular access device allowed)
- No concurrent investigational agent which would be considered as a treatment for the primary neoplasm
- No concurrent anticoagulants, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis
- No other concurrent treatment for prior malignancy (other than hormonal therapy)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm I (Phase II)
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
Dado IV
Administrado oralmente
|
|
Experimental: Arm II (Phase II)
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
Administrado oralmente
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Tolerated Dose (Phase I)
Periodo de tiempo: From baseline up to 3 years post treatment
|
MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table.
The number of dose limiting toxicities will be reported here.
|
From baseline up to 3 years post treatment
|
|
Time to Progression (TTP) (Phase II)
Periodo de tiempo: From baseline up to 3 years post treatment
|
Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up.
If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Kaplan-Meier survival curves will be used to estimate the distribution of TTP.
|
From baseline up to 3 years post treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival
Periodo de tiempo: Up to 3 years post treatment
|
Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.
Kaplan-Meier survival curves will be used to estimate the distribution of OS.
|
Up to 3 years post treatment
|
|
Tumor Response at 6 Months
Periodo de tiempo: 6 months
|
Tumor response (at 6 months) is defined as the number of responses (complete or partial response per Section 11) over the number of eligible patients observed for at least 6 months.
Tumor response will be evaluated using simple estimates of proportions.
|
6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2009
Finalización primaria (Actual)
1 de abril de 2012
Finalización del estudio (Actual)
1 de mayo de 2013
Fechas de registro del estudio
Enviado por primera vez
20 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
20 de marzo de 2009
Publicado por primera vez (Estimar)
23 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
23 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias
- Neoplasias por sitio
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la proteína quinasa
- Sorafenib
- Bevacizumab
Otros números de identificación del estudio
- NCCTG-N0745
- NCI-2009-01178 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- CDR0000637866 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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