Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
23 mars 2022 uppdaterad av: 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)
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Arizona
-
Scottsdale, Arizona, Förenta staterna, 85259-5499
- Mayo Clinic Scottsdale
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, Förenta staterna, 80301-9019
- Boulder Community Hospital
-
Colorado Springs, Colorado, Förenta staterna, 80933
- Penrose Cancer Center at Penrose Hospital
-
Denver, Colorado, Förenta staterna, 80210
- Porter Adventist Hospital
-
Denver, Colorado, Förenta staterna, 80220
- Rose Medical Center
-
Denver, Colorado, Förenta staterna, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Förenta staterna, 80204
- St. Anthony Central Hospital
-
Denver, Colorado, Förenta staterna, 80218
- St. Joseph Hospital
-
Denver, Colorado, Förenta staterna, 80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood, Colorado, Förenta staterna, 80110
- Swedish Medical Center
-
Grand Junction, Colorado, Förenta staterna, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Greeley, Colorado, Förenta staterna, 80631
- North Colorado Medical Center
-
Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, Förenta staterna, 80501
- Hope Cancer Care Center at Longmont United Hospital
-
Loveland, Colorado, Förenta staterna, 80539
- McKee Medical Center
-
Pueblo, Colorado, Förenta staterna, 81004
- St. Mary - Corwin Regional Medical Center
-
Thornton, Colorado, Förenta staterna, 80229
- North Suburban Medical Center
-
Wheat Ridge, Colorado, Förenta staterna, 80033
- Exempla Lutheran Medical Center
-
-
Connecticut
-
Hartford, Connecticut, Förenta staterna, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
-
-
Illinois
-
Bloomington, Illinois, Förenta staterna, 61701
- Illinois CancerCare - Bloomington
-
Bloomington, Illinois, Förenta staterna, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare - Canton
-
Canton, Illinois, Förenta staterna, 61520
- Graham Hospital
-
Carthage, Illinois, Förenta staterna, 62321
- Memorial Hospital
-
Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare - Carthage
-
Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare - Eureka
-
Eureka, Illinois, Förenta staterna, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare - Galesburg
-
Galesburg, Illinois, Förenta staterna, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, Förenta staterna, 62644
- Mason District Hospital
-
Havana, Illinois, Förenta staterna, 62644
- Illinois CancerCare - Havana
-
Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare - Kewanee Clinic
-
Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare - Macomb
-
Macomb, Illinois, Förenta staterna, 61455
- Mcdonough District Hospital
-
Moline, Illinois, Förenta staterna, 61265
-
Moline, Illinois, Förenta staterna, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
-
Monmouth, Illinois, Förenta staterna, 61462
- Illinois CancerCare - Monmouth
-
Monmouth, Illinois, Förenta staterna, 61462
- OSF Holy Family Medical Center
-
Normal, Illinois, Förenta staterna, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Förenta staterna, 61761
- Community Cancer Center
-
Normal, Illinois, Förenta staterna, 61761
- Illinois CancerCare - Community Cancer Center
-
Ottawa, Illinois, Förenta staterna, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Förenta staterna, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, Förenta staterna, 61554
- Cancer Treatment Center at Pekin Hospital
-
Pekin, Illinois, Förenta staterna, 61603
- Illinois CancerCare - Pekin
-
Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Förenta staterna, 61614
- Proctor Hospital
-
Peoria, Illinois, Förenta staterna, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Förenta staterna, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Förenta staterna, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare - Peru
-
Peru, Illinois, Förenta staterna, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Förenta staterna, 61356
- Perry Memorial Hospital
-
Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare - Princeton
-
Spring Valley, Illinois, Förenta staterna, 61362
- Illinois CancerCare - Spring Valley
-
-
Iowa
-
Bettendorf, Iowa, Förenta staterna, 52722
-
Clive, Iowa, Förenta staterna, 50325
- Medical Oncology and Hematology Associates - West Des Moines
-
Des Moines, Iowa, Förenta staterna, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Förenta staterna, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Förenta staterna, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Förenta staterna, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Förenta staterna, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Förenta staterna, 51104
- Mercy Medical Center - Sioux City
-
-
Kansas
-
Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas, PA - Chanute
-
Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas, PA - Dodge City
-
El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas, PA - El Dorado
-
Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
-
Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
-
Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas, PA - Kingman
-
Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, Förenta staterna, 67905
- Cancer Center of Kansas, PA - Liberal
-
Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas, PA - Newton
-
Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas, PA - Parsons
-
Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas, PA - Pratt
-
Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas, PA - Salina
-
Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas, PA - Wellington
-
Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
-
Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas, PA - Wichita
-
Wichita, Kansas, Förenta staterna, 67214
- CCOP - Wichita
-
Wichita, Kansas, Förenta staterna, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, Förenta staterna, 67208
- Associates in Womens Health, PA - North Review
-
Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas, PA - Winfield
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
-
Battle Creek, Michigan, Förenta staterna, 49017
- Battle Creek Health System Cancer Care Center
-
Big Rapids, Michigan, Förenta staterna, 49307
- Mecosta County Medical Center
-
Dearborn, Michigan, Förenta staterna, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
-
Escanaba, Michigan, Förenta staterna, 49431
- Green Bay Oncology, Limited - Escanaba
-
Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Butterworth Hospital at Spectrum Health
-
Grand Rapids, Michigan, Förenta staterna, 49503
- CCOP - Grand Rapids
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Lacks Cancer Center at Saint Mary's Health Care
-
Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
-
Iron Mountain, Michigan, Förenta staterna, 49801
- Dickinson County Healthcare System
-
Jackson, Michigan, Förenta staterna, 49201
- Foote Memorial Hospital
-
Lansing, Michigan, Förenta staterna, 48912-1811
- Sparrow Regional Cancer Center
-
Livonia, Michigan, Förenta staterna, 48154
- St. Mary Mercy Hospital
-
Muskegon, Michigan, Förenta staterna, 49443
- Mercy General Health Partners
-
Pontiac, Michigan, Förenta staterna, 48341-2985
- St. Joseph Mercy Oakland
-
Port Huron, Michigan, Förenta staterna, 48060
- Mercy Regional Cancer Center at Mercy Hospital
-
Saginaw, Michigan, Förenta staterna, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
-
Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
-
Warren, Michigan, Förenta staterna, 48093
- St. John Macomb Hospital
-
Wyoming, Michigan, Förenta staterna, 49519
- Metro Health Hospital
-
-
Minnesota
-
Bemidji, Minnesota, Förenta staterna, 56601
- MeritCare Bemidji
-
Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
-
Duluth, Minnesota, Förenta staterna, 55805-1983
- Duluth Clinic Cancer Center - Duluth
-
Duluth, Minnesota, Förenta staterna, 55805
- Miller - Dwan Medical Center
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
-
Fergus Falls, Minnesota, Förenta staterna, 56537
- Fergus Falls Medical Group, PA
-
Fridley, Minnesota, Förenta staterna, 55432
- Mercy and Unity Cancer Center at Unity Hospital
-
Hutchinson, Minnesota, Förenta staterna, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, Förenta staterna, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center - Minneapolis
-
Robbinsdale, Minnesota, Förenta staterna, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Cancer Center
-
Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital Cancer Care Center
-
Shakopee, Minnesota, Förenta staterna, 55379
- St. Francis Cancer Center at St. Francis Medical Center
-
Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Förenta staterna, 56201
- Willmar Cancer Center at Rice Memorial Hospital
-
Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology, PA - Woodbury
-
-
Missouri
-
Jefferson City, Missouri, Förenta staterna, 65109
- Goldschmidt Cancer Center
-
Saint Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Förenta staterna, 63141
- Comprehensive Cancer Care, PC
-
-
Montana
-
Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Förenta staterna, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, Förenta staterna, 59107-7000
- Billings Clinic - Downtown
-
Billings, Montana, Förenta staterna, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, Förenta staterna, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, Förenta staterna, 59405
- Sletten Cancer Institute at Benefis Healthcare
-
Havre, Montana, Förenta staterna, 59501
- Northern Montana Hospital
-
Helena, Montana, Förenta staterna, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Förenta staterna, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Förenta staterna, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Förenta staterna, 59901
- Kalispell Medical Oncology at KRMC
-
Missoula, Montana, Förenta staterna, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, Förenta staterna, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Förenta staterna, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Förenta staterna, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Förenta staterna, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Förenta staterna, 58122
- MeritCare Broadway
-
-
Oklahoma
-
Tulsa, Oklahoma, Förenta staterna, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Pennsylvania
-
Danville, Pennsylvania, Förenta staterna, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Förenta staterna, 18201
- Geisinger Hazleton Cancer Center
-
State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Wisconsin
-
Green Bay, Wisconsin, Förenta staterna, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Förenta staterna, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Förenta staterna, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc, Wisconsin, Förenta staterna, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Förenta staterna, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- St. Nicholas Hospital
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
-
Wyoming
-
Casper, Wyoming, Förenta staterna, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 120 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm I (Phase II)
Patients receive oral sorafenib tosylate on days 1-28 twice daily and bevacizumab IV on days 1 and 15.
|
Givet IV
Ges oralt
|
|
Experimentell: Arm II (Phase II)
Patients receive oral sorafenib tosylate twice daily on days 1-28.
|
Ges oralt
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum Tolerated Dose (Phase I)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2009
Primärt slutförande (Faktisk)
1 april 2012
Avslutad studie (Faktisk)
1 maj 2013
Studieregistreringsdatum
Först inskickad
20 mars 2009
Först inskickad som uppfyllde QC-kriterierna
20 mars 2009
Första postat (Uppskatta)
23 mars 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Sorafenib
- Bevacizumab
Andra studie-ID-nummer
- NCCTG-N0745
- NCI-2009-01178 (Registeridentifierare: CTRP (Clinical Trials Reporting System))
- CDR0000637866 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Lever cancer
-
Universidad Complutense de MadridRekrytering
-
Sisli Hamidiye Etfal Training and Research HospitalHar inte rekryterat ännuErfarenhet, livKalkon
-
Bournemouth UniversityDorset County Hospital NHS Foundation TrustAvslutadErfarenhet, livStorbritannien
-
Centre Hospitalier Universitaire DijonAvslutad
-
Université de Reims Champagne-ArdenneAvslutadAdolescenters emotionella och sexuella livFrankrike
-
Diakonie Kliniken ZschadraßChemnitz University of TechnologyAvslutadMantra Meditation | Mantra Meditation + Kroppsorienterad Yoga | Mantra Meditation + Etiskt Liv | Mantra Meditation + Kroppsorienterad Yoga + Etiskt livTyskland
-
University of California, Los AngelesVA Greater Los Angeles Healthcare SystemIndragenVeteranfamiljer | Familjekommunikation | Återintegrering av civilt livFörenta staterna
-
University of Texas at AustinHar inte rekryterat ännuTrauma i tidiga liv | Major depressiv sjukdomFörenta staterna
-
CalydialOZ'IRIS SantéAvslutadPatientengagemang | Patientmedverkan | Patientnöjdhet | Dialys | Patientrelationer, sjuksköterska | Erfarenhet, livFrankrike
-
University Hospital, Strasbourg, FranceRekrytering
Kliniska prövningar på bevacizumab
-
Blokhin's Russian Cancer Research CenterAktiv, inte rekryterandeGlioblastom | Anaplastiskt astrocytom | Pleomorft Xanthoastrocytom | Återkommande malignt gliomRyssland
-
National Cancer Institute (NCI)NRG OncologyAvslutadGlioblastom | Gliosarkom | Återkommande glioblastom | Oligodendrogliom | Jättecellsglioblastom | Återkommande hjärnneoplasmFörenta staterna, Kanada
-
National Cancer Institute (NCI)AvslutadAdenokarcinom i livmoderhalsen | Adenosquamous karcinom i livmoderhalsen | Livmoderhalscancer skivepitel, ej specificerat på annat sätt | Steg IVA livmoderhalscancer AJCC v6 och v7 | Återkommande livmoderhalscancer | Steg IV Livmoderhalscancer AJCC v6 och v7 | Steg IVB livmoderhalscancer AJCC v6...Förenta staterna
-
National Cancer Institute (NCI)Aktiv, inte rekryterandeÅterkommande fallopian Tube Carcinom | Återkommande äggstockscancer | Återkommande primärt peritonealt karcinom | Ovarialt klarcelligt cystadenocarcinom | Äggstocksendometrioid adenokarcinom | Ovarialt seröst cystadenocarcinom | Endometriellt klart cell adenokarcinom | Endometriellt seröst adenokarcinom och andra villkorFörenta staterna
-
M.D. Anderson Cancer CenterAktiv, inte rekryterandeSteg IB hepatocellulärt karcinom AJCC v8 | Steg II hepatocellulärt karcinom AJCC v8 | Resektabelt hepatocellulärt karcinom | Steg I hepatocellulärt karcinom AJCC v8 | Steg IA hepatocellulärt karcinom AJCC v8Förenta staterna
-
National Cancer Institute (NCI)Aktiv, inte rekryterandeÄggstocksendometrioid adenokarcinom | Primärt peritonealt höggradigt seröst adenokarcinom | Äggledaren Endometrioid Adenocarcinom | Platinaresistent fallopian Tube Carcinom | Platinaresistent primärt peritonealt karcinom | Ovarialt höggradigt seröst adenokarcinom | Platinaresistent äggstockscancer | Äggledaren höggradigt seröst adenokarcinomFörenta staterna, Kanada
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsAvslutadÅterkommande fallopian Tube Carcinom | Återkommande äggstockscancer | Återkommande primärt peritonealt karcinom | Platinaresistent fallopian Tube Carcinom | Platinaresistent primärt peritonealt karcinom | Platinaresistent äggstockscancer | Refraktärt ovariekarcinom | Eldfast äggledarkarcinom | Refraktärt...Förenta staterna
-
National Cancer Institute (NCI)Aktiv, inte rekryterandeÅterkommande glioblastomFörenta staterna
-
National Cancer Institute (NCI)Aktiv, inte rekryterandeMetastaserande alveolär mjukdel sarkom | Ooperabelt alveolärt mjukdelssarkomFörenta staterna
-
Jiangsu Cancer Institute & HospitalRekryteringÄggstockscancer Metastaserande | Äggstockscancer Metastaserande återkommandeKina