Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer

23. marts 2022 opdateret af: 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)

Studieoversigt

Status

Afsluttet

Betingelser

Leverkræft

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Arizona
  - Scottsdale, Arizona, Forenede Stater, 85259-5499
    - Mayo Clinic Scottsdale
- Colorado
  - Aurora, Colorado, Forenede Stater, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, Forenede Stater, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, Forenede Stater, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, Forenede Stater, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, Forenede Stater, 80220
    - Rose Medical Center
  - Denver, Colorado, Forenede Stater, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, Forenede Stater, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, Forenede Stater, 80218
    - St. Joseph Hospital
  - Denver, Colorado, Forenede Stater, 80224-2522
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, Forenede Stater, 80110
    - Swedish Medical Center
  - Grand Junction, Colorado, Forenede Stater, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, Forenede Stater, 80631
    - North Colorado Medical Center
  - Lone Tree, Colorado, Forenede Stater, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, Forenede Stater, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, Forenede Stater, 80539
    - McKee Medical Center
  - Pueblo, Colorado, Forenede Stater, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, Forenede Stater, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, Forenede Stater, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, Forenede Stater, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Illinois
  - Bloomington, Illinois, Forenede Stater, 61701
    - Illinois CancerCare - Bloomington
  - Bloomington, Illinois, Forenede Stater, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Forenede Stater, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, Forenede Stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Memorial Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Illinois CancerCare - Carthage
  - Eureka, Illinois, Forenede Stater, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Clinic, PC
  - Havana, Illinois, Forenede Stater, 62644
    - Mason District Hospital
  - Havana, Illinois, Forenede Stater, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, Forenede Stater, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Macomb, Illinois, Forenede Stater, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, Forenede Stater, 61455
    - Mcdonough District Hospital
  - Moline, Illinois, Forenede Stater, 61265
  - Moline, Illinois, Forenede Stater, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Monmouth, Illinois, Forenede Stater, 61462
    - Illinois CancerCare - Monmouth
  - Monmouth, Illinois, Forenede Stater, 61462
    - OSF Holy Family Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center
  - Normal, Illinois, Forenede Stater, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, Forenede Stater, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, Forenede Stater, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, Forenede Stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, Forenede Stater, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, Forenede Stater, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forenede Stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forenede Stater, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Forenede Stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forenede Stater, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Illinois CancerCare - Princeton
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Illinois CancerCare - Spring Valley
- Iowa
  - Bettendorf, Iowa, Forenede Stater, 52722
  - Clive, Iowa, Forenede Stater, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Des Moines, Iowa, Forenede Stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forenede Stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forenede Stater, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forenede Stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - Mercy Medical Center - Sioux City
- Kansas
  - Chanute, Kansas, Forenede Stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forenede Stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, Forenede Stater, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, Forenede Stater, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, Forenede Stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, Forenede Stater, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, Forenede Stater, 67905
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, Forenede Stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forenede Stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forenede Stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forenede Stater, 67401
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, Forenede Stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forenede Stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, Forenede Stater, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, Forenede Stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, Forenede Stater, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, Forenede Stater, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, Forenede Stater, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Escanaba, Michigan, Forenede Stater, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, Forenede Stater, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, Forenede Stater, 49201
    - Foote Memorial Hospital
  - Lansing, Michigan, Forenede Stater, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, Forenede Stater, 48154
    - St. Mary Mercy Hospital
  - Muskegon, Michigan, Forenede Stater, 49443
    - Mercy General Health Partners
  - Pontiac, Michigan, Forenede Stater, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, Forenede Stater, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, Forenede Stater, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Traverse City, Michigan, Forenede Stater, 49684
    - Munson Medical Center
  - Warren, Michigan, Forenede Stater, 48093
    - St. John Macomb Hospital
  - Wyoming, Michigan, Forenede Stater, 49519
    - Metro Health Hospital
- Minnesota
  - Bemidji, Minnesota, Forenede Stater, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forenede Stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, Forenede Stater, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, Forenede Stater, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, Forenede Stater, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, Forenede Stater, 56537
    - Fergus Falls Medical Group, PA
  - Fridley, Minnesota, Forenede Stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forenede Stater, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology Hematology, PA - Maplewood
  - Maplewood, Minnesota, Forenede Stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, Forenede Stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - Saint Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, Forenede Stater, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Stillwater, Minnesota, Forenede Stater, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forenede Stater, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Missouri
  - Jefferson City, Missouri, Forenede Stater, 65109
    - Goldschmidt Cancer Center
  - Saint Louis, Missouri, Forenede Stater, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, Forenede Stater, 63141
    - Comprehensive Cancer Care, PC
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forenede Stater, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, Forenede Stater, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, Forenede Stater, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forenede Stater, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Forenede Stater, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, Forenede Stater, 59501
    - Northern Montana Hospital
  - Helena, Montana, Forenede Stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forenede Stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, Forenede Stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forenede Stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forenede Stater, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Forenede Stater, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Forenede Stater, 58122
    - MeritCare Broadway
- Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Pennsylvania
  - Danville, Pennsylvania, Forenede Stater, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, Forenede Stater, 18201
    - Geisinger Hazleton Cancer Center
  - State College, Pennsylvania, Forenede Stater, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Medical X-Ray Center, PC
  - Sioux Falls, South Dakota, Forenede Stater, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Manitowoc, Wisconsin, Forenede Stater, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, Forenede Stater, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Oconto Falls, Wisconsin, Forenede Stater, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Sheboygan, Wisconsin, Forenede Stater, 53081
    - St. Nicholas Hospital
  - Sturgeon Bay, Wisconsin, Forenede Stater, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
- Wyoming
  - Casper, Wyoming, Forenede Stater, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, Forenede Stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Arm I (Phase II) Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.	Biologisk: bevacizumab Givet IV Medicin: sorafenib tosylat Gives oralt
Eksperimentel: Arm II (Phase II) Patients receive oral sorafenib tosylate twice daily on days 1-28.	Medicin: sorafenib tosylat Gives oralt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Maximum Tolerated Dose (Phase I) Tidsramme: 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) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Survival Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hubbard JM, Mahoney MR, Loui WS, Roberts LR, Smyrk TC, Gatalica Z, Borad M, Kumar S, Alberts SR. Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma: North Central Cancer Treatment Group Trial N0745 (Alliance). Target Oncol. 2017 Apr;12(2):201-209. doi: 10.1007/s11523-016-0467-0.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. april 2012

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

20. marts 2009

Først indsendt, der opfyldte QC-kriterier

20. marts 2009

Først opslået (Skøn)

23. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCCTG-N0745
NCI-2009-01178 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000637866 (Registry Identifier: PDQ (Physician Data Query))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Leverkræft

National Health Research Institutes, Taiwan

Rekruttering

Effekter af mindfulness eller hjernestimuleringsintervention for voksne i slutningen af livet i Taiwan Urban og landdistrikter (PredictNPI)

Mindfulness | Senlivsdepression | Voksne for sent liv | Prodromal depression af sent liv | Hjernestimuleringsintervention

Taiwan
Universidad Complutense de Madrid

Rekruttering

Meningsfokuseret intervention i hæren

Meningsfuldt liv

Spanien
L'Oreal

Rekruttering

Fotobeskyttelseseffektivitet med solcremeformler, der indeholder den cykliske merocyanin Long-UVA Absorber MCE, under ægte soleksponering

Pigmentering fra det virkelige liv

Indien
Université de Reims Champagne-Ardenne

Afsluttet

Støtte til Forældreskab: Uddannelse for Unge i Alderen 11 til 15 Års Følelsesmæssige og Seksuelle Liv (educ-parent)

Adolescentes følelsesmæssige og seksuelle liv

Frankrig
Sisli Hamidiye Etfal Training and Research Hospital

Ikke rekrutterer endnu

Vores anæstesioplevelser i hepatopancreatobiliær kirurgi: en retrospektiv undersøgelse

Erfaring, liv

Kalkun
Bournemouth University
Dorset County Hospital NHS Foundation Trust

Afsluttet

Implementering af babyvenligt initiativ: Barselspersonalets erfaringer

Erfaring, liv

Det Forenede Kongerige
University of California, Los Angeles
VA Greater Los Angeles Healthcare System

Trukket tilbage

UCLA FOCUS Forskningsundersøgelse om familieresiliency Training (FOCUS)

Veteranfamilier | Familiekommunikation | Civilt liv reintegration

Forenede Stater
Swiss Federal Institute of Technology

Afsluttet

Gennemførlighed og effektivitet af et hjemmebaseret motorkognitivt træningsprogram hos ældre voksne (COCARE)

Ældret | Uafhængigt liv

Schweiz
Diakonie Kliniken Zschadraß
Chemnitz University of Technology

Afsluttet

Meditationsbaseret livsstilsændring hos raske individer (MBLM-H)

Mantra meditation | Mantra Meditation + Kropsorienteret Yoga | Mantra Meditation + Etisk Liv | Mantra Meditation + Kropsorienteret Yoga + Etisk Liv

Tyskland
Calydial
OZ'IRIS Santé

Afsluttet

Hvad repræsenterer patientoplevelsen for patienter og plejere i dialyse? (EnquêteXP)

Patientengagement | Patientdeltagelse | Patienttilfredshed | Dialyse | Patientforhold, Sygeplejerske | Erfaring, liv

Frankrig

Kliniske forsøg med bevacizumab

National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

TORC1/2-hæmmer MLN0128 og Bevacizumab til behandling af patienter med tilbagevendende glioblastom eller avancerede solide tumorer

Tilbagevendende æggelederkarcinom | Tilbagevendende ovariekarcinom | Tilbagevendende primært peritonealt karcinom | Klarcellet ovariecystadenocarcinom | Ovarial Endometrioid Adenocarcinom | Serøst cystadenocarcinom i æggestokkene | Endometrie clear cell adenocarcinoma | Endometrial serøst adenokarcinom | Fase IIIA Æggelederkræft AJCC... og andre forhold

Forenede Stater
National Cancer Institute (NCI)
NRG Oncology

Afsluttet

Bevacizumab med eller uden trebananib til behandling af patienter med tilbagevendende hjernetumorer

Glioblastom | Gliosarkom | Tilbagevendende glioblastom | Oligodendrogliom | Kæmpecelleglioblastom | Tilbagevendende hjerneneoplasma

Forenede Stater, Canada
Blokhin's Russian Cancer Research Center

Aktiv, ikke rekrutterende

Omfattende analyse af kemoterapi- og målrettet terapi-resultater ved recidiverende maligne gliomer (GLIOTARG)

Glioblastom | Anaplastisk astrocytom | Pleomorfisk xanthoastrocytom | Tilbagevendende malignt gliom

Rusland
National Cancer Institute (NCI)

Afsluttet

Atezolizumab og Bevacizumab til behandling af patienter med tilbagevendende, vedvarende eller metastatisk livmoderhalskræft

Cervikal Adenocarcinom | Cervikal Adenosquamous Carcinom | Cervikal planocellulært karcinom, ikke andet specificeret | Stadie IVA Livmoderhalskræft AJCC v6 og v7 | Tilbagevendende cervikal karcinom | Stadie IV Livmoderhalskræft AJCC v6 og v7 | Stadie IVB Livmoderhalskræft AJCC v6 og v7

Forenede Stater
Roswell Park Cancer Institute
Merck Sharp & Dohme LLC; United States Department of Defense; Celldex Therapeutics

Rekruttering

Pembrolizumab kombineret med Bevacizumab med eller uden agonist Anti-CD40 CDX-1140 til behandling af patienter med tilbagevendende ovariecancer

Tilbagevendende æggelederkarcinom | Tilbagevendende ovariekarcinom | Tilbagevendende primært peritonealt karcinom | Tilbagevendende endometrie serøs adenokarcinom | Ovarial klarcellet adenokarcinom | Tilbagevendende platinresistent ovariekarcinom | Platinfølsomt ovariekarcinom | Tilbagevendende æggelederendometrioid... og andre forhold

Forenede Stater
M.D. Anderson Cancer Center

Aktiv, ikke rekrutterende

Atezolizumab og Bevacizumab før operation til behandling af resektabel leverkræft

Stadie IB hepatocellulært karcinom AJCC v8 | Fase II hepatocellulært karcinom AJCC v8 | Resektabelt hepatocellulært karcinom | Stadie I hepatocellulært karcinom AJCC v8 | Stadie IA hepatocellulært karcinom AJCC v8

Forenede Stater
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Bevacizumab og Anetumab Ravtansin eller Paclitaxel til behandling af patienter med refraktær ovarie-, æggeleder- eller primær peritonealcancer

Ovarial Endometrioid Adenocarcinom | Primært peritonealt højgradigt serøst adenokarcinom | Æggeleder endometrioid adenokarcinom | Platin-resistent æggelederkarcinom | Platin-resistent primært peritonealt karcinom | Ovarial højgradigt serøst adenokarcinom | Platin-resistent ovariekarcinom | Æggeleder...

Forenede Stater, Canada
Northwestern University
National Cancer Institute (NCI); Ipsen Biopharmaceuticals

Afsluttet

Irinotecan Liposome og Bevacizumab til behandling af platinresistent, tilbagevendende eller refraktær kræft i æggestokkene, æggelederen eller primær peritoneal cancer

Tilbagevendende æggelederkarcinom | Tilbagevendende ovariekarcinom | Tilbagevendende primært peritonealt karcinom | Platin-resistent æggelederkarcinom | Platin-resistent primært peritonealt karcinom | Platin-resistent ovariekarcinom | Ildfast ovariekarcinom | Ildfast æggelederkarcinom | Refraktær Primær...

Forenede Stater
National Cancer Institute (NCI)

Aktiv, ikke rekrutterende

Cediranib Maleate og Olaparib sammenlignet med Bevacizumab til behandling af patienter med tilbagevendende glioblastom

Tilbagevendende glioblastom

Forenede Stater
Mayo Clinic
National Cancer Institute (NCI)

Afsluttet

Nab-Paclitaxel og Bevacizumab til behandling af patienter med uoperabelt stadium IV melanom eller gynækologisk kræft

Ondartet fast neoplasma | Ovarial Endometrioid Adenocarcinom | Ovarialt udifferentieret karcinom | Cervikal Adenocarcinom | Cervikal Adenosquamous Carcinom | Ondartet peritoneal neoplasma | Endometrie clear cell adenocarcinoma | Endometrie Endometrioid Adenocarcinom | Endometrie blandet cellet adenokarcinom og andre forhold

Forenede Stater

Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Leverkræft

Kliniske forsøg med bevacizumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer