Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:October 28, 2009

Use our guide to learn which trials are right for you!

A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion

This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how
well they work compared with chemoembolization alone in treating patients with liver cancer
that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin
hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels
near the tumor and then blocking the blood flow to allow a higher concentration of the drug
to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of
tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known
whether giving chemoembolization together with sorafenib tosylate is more effective than
chemoembolization alone in treating patients with liver cancer.

PRIMARY OBJECTIVE:

I. To compare progression-free survival (PFS) of chemoembolization alone to sorafenib
(sorafenib tosylate) in combination with chemoembolization.

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) of chemoembolization alone to sorafenib in combination
with chemoembolization.

II. To evaluate extra-hepatic versus intra-hepatic patterns of failure. III. To determine the
rates of toxicity related to sorafenib in combination with chemoembolization.

TERTIARY OBJECTIVES:

I. To analyze the pharmacogenetic and pharmacokinetic properties of sorafenib including
angiogenesis, monooxygenases, polymorphisms and multidrug resistance (MDR).

II. Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network
(ACRIN) secondary imaging objective: site versus (vs.) central evaluation of PFS.

III. To determine the inter-reader concordance for response characterization at four and
eight months by the European Association for the Study of Liver (EASL) criteria.

IV. To determine the value of objective tumor response at four and eight months by the EASL
criteria to predict PFS (by Response Evaluation Criteria in Solid Tumors [RECIST]) and OS.

V. To evaluate the effects of intra-hepatic vs. extra-hepatic progression on OS.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sorafenib tosylate orally (PO) twice daily (BID) in the absence of
disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of
sorafenib tosylate is reached, patients undergo transarterial chemoembolization (TACE)
comprising doxorubicin hydrochloride, mitomycin C, and cisplatin (closed to accrual as of
10/1/2010); conventional chemoembolization comprising doxorubicin hydrochloride only; or
chemoembolization comprising doxorubicin-eluting beads. Treatment with TACE repeats
approximately every 4 weeks for up to 4 courses in the absence of disease progression or
unacceptable toxicity.

ARM II: Patients receive placebo PO BID in the absence of disease progression or unacceptable
toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients
undergo TACE as in Arm I.

MAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib
tosylate or placebo as in Arm I and II in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed up for 4 years.

Inclusion Criteria:

- Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion
listed below:

- Histologically confirmed

- Magnetic resonance imaging (MRI) or computerized tomography (CT) consistent with
liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement
and delayed enhancement washout regardless of alpha-feto protein levels (AFP)

- AFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless
of specific imaging characteristics on CT or MRI

- Patients must have hepatocellular carcinoma (HCC) limited to the liver; there must be
no clinical or radiographic evidence of extrahepatic HCC

- Portal lymphadenopathy IS permitted for patients with hepatitis B virus (HBV) or
hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis
unrelated to malignancy

- Staging CT of the chest and CT or MRI of the abdomen and pelvis must have been
completed within 4 weeks of study registration

- Patients must have measurable disease constituting < 50% of liver parenchyma within 4
weeks of registration

- Patients may not have ascites detectable on physical examination

- Patients must not be candidates for curative resection, orthotopic liver
transplantation, or radiofrequency ablation (RFA)

- Patients may have been treated with RFA in the past, but no sooner than 4 weeks before
study registration

- Patients may have undergone previously attempted curative liver resection

- Patients may NOT have been previously treated with brachytherapy such as yttrium-90
microsphere

- Patients may NOT have been previously treated with sorafenib, chemoembolization, or
systemic chemotherapy including cytotoxic agents or molecularly targeted agents

- Branch portal vein invasion by tumor is permitted but patients with main portal vein
invasion by tumor are not eligible

- Patients must have Child-Pugh score of A or B7 within 4 weeks prior to study
registration

- Serum total bilirubin =< 2.0 mg/dL

- Alkaline phosphatase < 5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN

- Serum creatinine =< 1.5 mg/dL

- Platelet count >= 50,000/mm^3

- Patients must not have any evidence of bleeding diathesis or active gastrointestinal
bleeding

- Patients must have no clinical signs of heart failure and meet New York Heart
Association functional classification I or II defined as:

- Class I - patients with no limitation of activities; they suffer no symptoms from
ordinary activities

- Class II - patients with slight, mild limitation of activity; they are
comfortable with rest or with mild exertion

- Patients must have an ECOG performance status of 0 or 1

- Patients must have a life expectancy of at least 3 months

- Patients must not be known to be human immunodeficiency virus (HIV) positive

- Patients must not have other uncontrolled intercurrent illnesses excluding HBV or HCV,
including, but not limited to: uncontrolled hypertension, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive
disorders that would limit compliance with study requirements

- Uncontrolled hypertension is defined as optimally treated baseline blood pressure
that exceeds 150/90 mm Hg

- Patients must not be taking cytochrome P450 enzyme inducing drugs

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to registration to rule out
pregnancy

- Women of childbearing potential and sexually active males must be strongly advised to
use an accepted and effective method of contraception

- Patients must not have an allergy to iodine or gadolinium contrast that cannot be
safely controlled with premedication

- Patient must be able to swallow pills, as study medications cannot be crushed
We found this trial at
282
sites
?
mi
from
Topeka, KS
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
?
mi
from
Flint, MI
Click here to add this to my saved trials
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
?
mi
from
Galveston, TX
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
?
mi
from
Macon, GA
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
98-1079 Moanalua Road
'Aiea, Hawaii 96701
?
mi
from
'Aiea, HI
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Auburn, Washington 98001
?
mi
from
Auburn, WA
Click here to add this to my saved trials
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1500 Red River Street
Austin, Texas 78701
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21229
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
1233 North 30th Street
Billings, Montana 59101
406-237-7000
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
Bloomington, Illinois 61701
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Burien, Washington 98166
?
mi
from
Burien, WA
Click here to add this to my saved trials
Burlington, Massachusetts 01805
?
mi
from
Burlington, MA
Click here to add this to my saved trials
201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
400 South Clark Street
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Canton, Illinois 61520
?
mi
from
Canton, IL
Click here to add this to my saved trials
210 W Walnut St
Canton, Illinois 61520
309-647-5240
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Canton, IL
Click here to add this to my saved trials
160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
?
mi
from
Carthage, IL
Click here to add this to my saved trials
1454 North County Road 2050
Carthage, Illinois 62321
(217) 357-8500
Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
?
mi
from
Carthage, IL
Click here to add this to my saved trials
6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
?
mi
from
Casper, WY
Click here to add this to my saved trials
Centralia, Washington 98531
?
mi
from
Centralia, WA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60625
?
mi
from
Chicago, IL
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Clive, IA
Click here to add this to my saved trials
1400 East Boulder Street
Colorado Springs, Colorado 80909
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Missouri 65201
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
?
mi
from
Danville, PA
Click here to add this to my saved trials
Dearborn, Michigan 48124
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
Decatur, Illinois 62526
?
mi
from
Decatur, IL
Click here to add this to my saved trials
2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
?
mi
from
Denver, CO
Click here to add this to my saved trials
1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Mercy Medical Center - Des Moines Mercy Medical Center
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48236
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Easley, SC
Click here to add this to my saved trials
6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
?
mi
from
Edina, MN
Click here to add this to my saved trials
Elkton, Maryland 21921
?
mi
from
Elkton, MD
Click here to add this to my saved trials
Eureka, Illinois 61530
?
mi
from
Eureka, IL
Click here to add this to my saved trials
101 S Major St
Eureka, Illinois 61530
309-467-2371
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Eureka, IL
Click here to add this to my saved trials
Evanston, Illinois 60202
?
mi
from
Evanston, IL
Click here to add this to my saved trials
1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
?
mi
from
Everett, WA
Click here to add this to my saved trials
Federal Way, Washington 98003
?
mi
from
Federal Way, WA
Click here to add this to my saved trials
420 S Saginaw St
Flint, Michigan 48502
810-232-3522
Genesys Regional Medical Center-West Flint Campus The health care team at Genesys Downtown Flint Health...
?
mi
from
Flint, MI
Click here to add this to my saved trials
550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
?
mi
from
Fridley, MN
Click here to add this to my saved trials
?
mi
from
Fruitland, ID
Click here to add this to my saved trials
3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
?
mi
from
Galesburg, IL
Click here to add this to my saved trials
Grand Island, Nebraska 68803
?
mi
from
Grand Island, NE
Click here to add this to my saved trials
Grand Junction, Colorado 81502
?
mi
from
Grand Junction, CO
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
1117 29th St S
Great Falls, Montana 59405
(406) 771-7300
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
1400 29th Street South
Great Falls, Montana 59405
406-454-2171
Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
Greenville, South Carolina 29601
?
mi
from
Greenville, SC
Click here to add this to my saved trials
1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
24800 SE Stark St
Gresham, Oregon 97030
(503) 674-1122
Legacy Mount Hood Medical Center Legacy Mount Hood Medical Center, East County's full-service community hospital,...
?
mi
from
Gresham, OR
Click here to add this to my saved trials