Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
23 maart 2022 bijgewerkt door: 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)
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
24
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Aurora, Colorado, Verenigde Staten, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Verenigde Staten, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Verenigde Staten, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Verenigde Staten, 80210
- Porter Adventist Hospital
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Denver, Colorado, Verenigde Staten, 80220
- Rose Medical Center
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Denver, Colorado, Verenigde Staten, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Verenigde Staten, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Verenigde Staten, 80218
- St. Joseph Hospital
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Denver, Colorado, Verenigde Staten, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Verenigde Staten, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Verenigde Staten, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Verenigde Staten, 80631
- North Colorado Medical Center
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Lone Tree, Colorado, Verenigde Staten, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Verenigde Staten, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Verenigde Staten, 80539
- McKee Medical Center
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Pueblo, Colorado, Verenigde Staten, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Verenigde Staten, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Verenigde Staten, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Verenigde Staten, 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, Verenigde Staten, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Verenigde Staten, 61701
- St. Joseph Medical Center
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Canton, Illinois, Verenigde Staten, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Verenigde Staten, 61520
- Graham Hospital
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Carthage, Illinois, Verenigde Staten, 62321
- Memorial Hospital
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Carthage, Illinois, Verenigde Staten, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Verenigde Staten, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Verenigde Staten, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Verenigde Staten, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Verenigde Staten, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Verenigde Staten, 62644
- Mason District Hospital
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Havana, Illinois, Verenigde Staten, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Verenigde Staten, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Verenigde Staten, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Verenigde Staten, 61455
- Mcdonough District Hospital
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Moline, Illinois, Verenigde Staten, 61265
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Moline, Illinois, Verenigde Staten, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Verenigde Staten, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Verenigde Staten, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Verenigde Staten, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Verenigde Staten, 61761
- Community Cancer Center
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Normal, Illinois, Verenigde Staten, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Verenigde Staten, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Verenigde Staten, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Verenigde Staten, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Verenigde Staten, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Verenigde Staten, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Verenigde Staten, 61614
- Proctor Hospital
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Peoria, Illinois, Verenigde Staten, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Verenigde Staten, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Verenigde Staten, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Verenigde Staten, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Verenigde Staten, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Verenigde Staten, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Verenigde Staten, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Verenigde Staten, 61362
- Illinois CancerCare - Spring Valley
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Iowa
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Bettendorf, Iowa, Verenigde Staten, 52722
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Clive, Iowa, Verenigde Staten, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Verenigde Staten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Verenigde Staten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Sioux City, Iowa, Verenigde Staten, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Verenigde Staten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Verenigde Staten, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, Verenigde Staten, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Verenigde Staten, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Verenigde Staten, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Verenigde Staten, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Verenigde Staten, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Verenigde Staten, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Verenigde Staten, 67905
- Cancer Center of Kansas, PA - Liberal
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Newton, Kansas, Verenigde Staten, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Verenigde Staten, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Verenigde Staten, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Verenigde Staten, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Verenigde Staten, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Verenigde Staten, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Verenigde Staten, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Verenigde Staten, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Verenigde Staten, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Verenigde Staten, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Verenigde Staten, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Verenigde Staten, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Verenigde Staten, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Verenigde Staten, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Verenigde Staten, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Verenigde Staten, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Verenigde Staten, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Verenigde Staten, 48154
- St. Mary Mercy Hospital
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Muskegon, Michigan, Verenigde Staten, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Verenigde Staten, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Verenigde Staten, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Verenigde Staten, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Traverse City, Michigan, Verenigde Staten, 49684
- Munson Medical Center
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Warren, Michigan, Verenigde Staten, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Verenigde Staten, 49519
- Metro Health Hospital
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Minnesota
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Bemidji, Minnesota, Verenigde Staten, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Verenigde Staten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Verenigde Staten, 55805
- CCOP - Duluth
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Duluth, Minnesota, Verenigde Staten, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Verenigde Staten, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, Verenigde Staten, 56537
- Fergus Falls Medical Group, PA
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Fridley, Minnesota, Verenigde Staten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Verenigde Staten, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Verenigde Staten, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Verenigde Staten, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Verenigde Staten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, Verenigde Staten, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Stillwater, Minnesota, Verenigde Staten, 55082
- Lakeview Hospital
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Waconia, Minnesota, Verenigde Staten, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Verenigde Staten, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Verenigde Staten, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Missouri
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Jefferson City, Missouri, Verenigde Staten, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, Verenigde Staten, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Verenigde Staten, 63141
- Comprehensive Cancer Care, PC
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Verenigde Staten, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Verenigde Staten, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Verenigde Staten, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Verenigde Staten, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Verenigde Staten, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Verenigde Staten, 59501
- Northern Montana Hospital
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Helena, Montana, Verenigde Staten, 59601
- St. Peter's Hospital
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Verenigde Staten, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Verenigde Staten, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Verenigde Staten, 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, Verenigde Staten, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Verenigde Staten, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Verenigde Staten, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Verenigde Staten, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Verenigde Staten, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Verenigde Staten, 58122
- MeritCare Broadway
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Danville, Pennsylvania, Verenigde Staten, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Verenigde Staten, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Verenigde Staten, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Verenigde Staten, 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, Verenigde Staten, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Verenigde Staten, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Verenigde Staten, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Wisconsin
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Green Bay, Wisconsin, Verenigde Staten, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Verenigde Staten, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Verenigde Staten, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Manitowoc, Wisconsin, Verenigde Staten, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Verenigde Staten, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, Verenigde Staten, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sheboygan, Wisconsin, Verenigde Staten, 53081
- St. Nicholas Hospital
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Sturgeon Bay, Wisconsin, Verenigde Staten, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wyoming
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Casper, Wyoming, Verenigde Staten, 82609
- Rocky Mountain Oncology
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Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 120 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm I (Phase II)
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
IV gegeven
Mondeling gegeven
|
|
Experimenteel: Arm II (Phase II)
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
Mondeling gegeven
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maximum Tolerated Dose (Phase I)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2009
Primaire voltooiing (Werkelijk)
1 april 2012
Studie voltooiing (Werkelijk)
1 mei 2013
Studieregistratiedata
Eerst ingediend
20 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
20 maart 2009
Eerst geplaatst (Schatting)
23 maart 2009
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 april 2022
Laatste update ingediend die voldeed aan QC-criteria
23 maart 2022
Laatst geverifieerd
1 maart 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Neoplasmata van het spijsverteringsstelsel
- Lever Ziekten
- Lever neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Proteïnekinaseremmers
- Sorafenib
- Bevacizumab
Andere studie-ID-nummers
- NCCTG-N0745
- NCI-2009-01178 (Register-ID: CTRP (Clinical Trials Reporting System))
- CDR0000637866 (Register-ID: PDQ (Physician Data Query))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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