Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer



Status:Active, not recruiting
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:February 15, 2010

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

Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to
see how well they work compared with sorafenib tosylate alone in treating patients with liver
cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the
body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. It is not yet known whether
giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than
sorafenib tosylate alone in treating liver cancer.

PRIMARY OBJECTIVES:

I. Compare the overall survival (OS) of patients treated with sorafenib (sorafenib tosylate)
and doxorubicin (doxorubicin hydrochloride) to that of those treated with sorafenib.

SECONDARY OBJECTIVES:

I. Compare time to progression (TTP) of patients treated with sorafenib and doxorubicin to
that of those treated with sorafenib.

II. Compare progression-free-survival (PFS) of patients treated with sorafenib and
doxorubicin to that of those treated with sorafenib.

III. Compare tumor response using Response Evaluation Criteria in Solid Tumors (RECIST)
criteria of patients treated with sorafenib and doxorubicin to that of those treated with
sorafenib.

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

ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) on day 1 and sorafenib
tosylate orally (PO) once daily (QD) or twice daily (BID) on days 1-21. Treatment repeats
every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for 2 years.

Inclusion Criteria:

- Patients must have pathologically or cytologically proven hepatocellular carcinoma;
known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or
fibrolamellar variant is not allowed

- Patients must have locally advanced or metastatic disease; locally advanced disease is
defined as disease deemed to be unresectable or non-eligible for transplant without
distant metastases

- Lesions must be accurately measurable in at least one dimension (longest diameter to
be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral
computed tomography (CT) scan

- No prior adjuvant sorafenib or other v-RAF-1 murine leukemia viral oncogene homolog
(Raf)/vascular endothelial growth factor (VEGF) inhibitors; other prior adjuvant
therapy is allowed if completed > 6 months prior to registration with documented
recurrence of hepatocellular carcinoma (HCC)

- Patients may have been treated with loco regional therapies provided that they either
have:

- A target lesion that has not been subjected to local therapy or

- The target lesion(s) within the field of the local therapy has shown an increase
of >= 20% in the size since last treatment

- Such therapy must be completed at least 4 weeks prior to registration;
patients that have received palliative radiation therapy to the bone need
not wait 4 weeks to begin protocol therapy

- Prior therapies allowed include the following:

- Bland embolization, radiation, radioactive microspheres, etc

- Chemoembolization using any chemotherapy (except, see below)

- Chemoembolization drug-eluting beads using doxorubicin

- Prior therapy with chemoembolization using doxorubicin in the non drug eluting
beads form is NOT allowed

- No prior systemic therapy for metastatic disease

- No prior exposure to systemic doxorubicin administered intravenously

- Antiviral treatment is allowed, however interferon therapy must be stopped at least 4
weeks prior to registration

- Allografts are not allowed: no prior history of any allograft, including but not
limited to liver and bone marrow transplants

- Patients must have completed any major surgery >= 4 weeks from registration

- Concomitant treatment with Rifampin or St John's wort is not allowed; patients should
discontinue these drugs at least 4 weeks prior to registration

- No known central nervous system (CNS) tumors including brain metastases

- No clinically significant gastrointestinal bleeding events requiring intervention,
transfusion, or admission to hospital within 30 days prior to registration

- Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on a
regimen of anti-hypertensive therapy

- Significant history of cardiac disease is not allowed:

- Congestive heart failure > class II New York Heart Association (NYHA)

- Myocardial infarction within 6 months prior to registration

- Serious myocardial dysfunction, defined as scintigraphically (multigated
acquisition scan [MUGA], myocardial scintigram) determined absolute left
ventricular ejection fraction (LVEF) below 45% or an LVEF on echocardiogram
(ECHO) below the normal limit at the individual institution

- No history of bleeding diathesis

- Patients receiving combination anti-retroviral therapy for human immunodeficiency
virus (HIV) are excluded from the study

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Pregnancy/nursing status: women who are pregnant should not go on study; women should
not breastfeed while participating in this study

- Granulocytes >= 1,500/uL

- Hemoglobin >= 8.5 g/dL; patients with recent or ongoing gastrointestinal bleed may not
be transfused to reach the entry hemoglobin of 8.5 g/dL; physicians should ensure
patients requiring transfusion prior to registration do not have an occult or
clinically apparent gastrointestinal bleed

- Platelets >= 75,000/uL

- Creatinine =< 1.5 x upper limit of normal (ULN) (or creatinine clearance calculated >=
60 cc/minute)

- Child-Pugh score A; patients must meet all laboratory value requirements

- Bilirubin =< 3 mg/dL

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 x ULN

- Prothrombin time (PT)-international normalized ratio (INR) =< 1.7 (not required for
patients on anticoagulation agents; patients who are being therapeutically
anticoagulated with an agent such as Coumadin or heparin will be allowed to
participate provided that no prior evidence of underlying abnormality in these
parameters exists)
We found this trial at
662
sites
?
mi
from
Mattoon, IL
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
Bremerton, Washington 98310
?
mi
from
Bremerton, WA
Click here to add this to my saved trials
1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
?
mi
from
Burlington, VT
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
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
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
?
mi
from
Las Vegas, NV
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
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
?
mi
from
Spokane, WA
Click here to add this to my saved trials
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
?
mi
from
Valhalla, NY
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
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
?
mi
from
Abington, PA
Click here to add this to my saved trials
818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
?
mi
from
Adrian, MI
Click here to add this to my saved trials
Adrian, Michigan 49221
?
mi
from
Adrian, MI
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
Allentown, Pennsylvania 18103
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Altamonte Springs, Florida 32701
?
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
Ames, Iowa 50010
?
mi
from
Ames, IA
Click here to add this to my saved trials
Anacortes, Washington 98221
?
mi
from
Anacortes, WA
Click here to add this to my saved trials
Anaheim, California 92806
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
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
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
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
Antigo, Wisconsin 54409
?
mi
from
Antigo, WI
Click here to add this to my saved trials
?
mi
from
Antioch, CA
Click here to add this to my saved trials
921 North Oak Park Boulevard
Arroyo Grande, California 93420
?
mi
from
Arroyo Grande, CA
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Asheville, North Carolina 28816
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Asheville, North Carolina 28803
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Auburn, NY
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
2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
?
mi
from
Aurora, IL
Click here to add this to my saved trials
Bainbridge Island, Washington 98110
?
mi
from
Bainbridge Island, WA
Click here to add this to my saved trials
Baldwin Park, California 91706
?
mi
from
Baldwin Park, CA
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
2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
?
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
155 5th St NE
Barberton, Ohio 44203
(330) 615-3000
Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
?
mi
from
Barberton, OH
Click here to add this to my saved trials
4305 New Shepherdsville Road
Bardstown, Kentucky 40004
?
mi
from
Bardstown, KY
Click here to add this to my saved trials
Baton Rouge, Louisiana 70806
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70806
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70805
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
4950 Essen Lane
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beech Grove, Indiana 46107
?
mi
from
Beech Grove, IN
Click here to add this to my saved trials
205 Palmer Ave.
Bellefontaine, Ohio 43311
937.592.4015
Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
?
mi
from
Bellefontaine, OH
Click here to add this to my saved trials
Bellevue, Washington 98004
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Bellflower, California 90706
?
mi
from
Bellflower, CA
Click here to add this to my saved trials
Bellingham, Washington 98225
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
?
mi
from
Belpre, OH
Click here to add this to my saved trials
?
mi
from
Berlin, VT
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
900 East Broadway
Bismarck, North Dakota 58501
701.530.7000
Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
?
mi
from
Bismarck, ND
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
Bolivar, Missouri 65613
?
mi
from
Bolivar, MO
Click here to add this to my saved trials
Bonne Terre, Missouri 63628
?
mi
from
Bonne Terre, MO
Click here to add this to my saved trials
Boone, Iowa 50036
?
mi
from
Boone, IA
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
960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
?
mi
from
Bowling Green, OH
Click here to add this to my saved trials
?
mi
from
Brainerd, MN
Click here to add this to my saved trials
Branson, Missouri 65616
?
mi
from
Branson, MO
Click here to add this to my saved trials
?
mi
from
Bremerton, WA
Click here to add this to my saved trials
Brevard, North Carolina 28612
?
mi
from
Brevard, NC
Click here to add this to my saved trials
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Bronx, New York 10468
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buffalo, 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
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
Butler, Pennsylvania 16001
?
mi
from
Butler, PA
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
?
mi
from
Camden, NJ
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
2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
?
mi
from
Canton, OH
Click here to add this to my saved trials
211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials