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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentTemporarily closed18 and overNCINCI-2011-01989
CDR0000659348, CALGB 80802, U10CA031946, NCT01015833

Trial Description

Summary

This randomized phase III trial is studying sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with locally advanced or metastatic liver cancer. 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.

Further Study Information

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. Treatment repeats 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.

Eligibility Criteria

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 "D", 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
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
  • Serious myocardial dysfunction, defined as scintigraphically (multigated acquisition scan [MUGA], myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF 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/μL
  • 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/μL
  • Creatinine =< 1.5 times 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 (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)

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Ghassan Abou-AlfaPrincipal Investigator

Trial Sites

U.S.A.
Arkansas
  Jonesboro
 NEA Medical Clinic - East Matthews
 Carroll Dean Scroggin Ph: 888-823-5923
  Email: ctsucontact@westat.com
California
  Dublin
 Epic Care-Dublin
 James H. Feusner Ph: 510-450-7600
  Orange
 St. Joseph Hospital Regional Cancer Center - Orange
 Timothy E Byun Ph: 714-734-6220
  Pleasant Hill
 East Bay Medical Oncology Hematology Associates - Pleasant Hill
 James H. Feusner Ph: 510-450-7600
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Alan Paul Venook Ph: 877-827-3222
District of Columbia
  Washington
 Veterans Affairs Medical Center - Washington, DC
 Steven H Krasnow Ph: 877-328-2621
Florida
  Pensacola
 Sacred Heart Cancer Center at Sacred Heart Hospital
 Dee McLeod Ph: 850-416-4611
 Sacred Heart Medical Oncology Group
 Dee McLeod Ph: 850-416-4611
Idaho
  Lewiston
 St. Joseph Regional Medical Center
 Yoshio Inoue Ph: 253-403-2394
Illinois
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Manhattan
 Cancer Center of Kansas-Manhattan
 Shaker R. Dakhil Ph: 316-262-4467
  McPherson
 Cancer Center of Kansas, PA - McPherson
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Dennie V Jones Ph: 859-257-3379
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Jyotsna Fuloria Ph: 888-562-4763
  Covington
 Ochsner Health Center - Covington
 Jyotsna Fuloria Ph: 888-562-4763
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Jyotsna Fuloria Ph: 888-562-4763
Maryland
  Baltimore
 St. Agnes Hospital Cancer Center
 Carole Miller Ph: 410-368-2910
Massachusetts
  Boston
 Boston University Cancer Research Center
 Kevan Leighton Hartshorn Ph: 617-638-8265
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Edina
 Fairview Southdale Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Hutchinson
 Hutchinson Area Health Care
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Minnesota Oncology - Maplewood
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  New Ulm
 New Ulm Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 Park Nicollet Cancer Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Saint Paul
 Regions Hospital Cancer Care Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
 United Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Stillwater
 Lakeview Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Waconia
 Ridgeview Medical Center
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Woodbury
 Minnesota Oncology - Woodbury
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Louis V Puneky Ph: 601-815-6700
Missouri
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Allan Ellerton Ph: 702-384-0013
  Reno
 Saint Mary's Regional Medical Center
 Vodur S Reddy Ph: 775-770-3854
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Teresa L Rutledge Ph: 505-272-6972
New York
  Bronx
 Veterans Affairs Medical Center - Bronx
 Yeun-Hee A Park Ph: 212-305-8615
  New York
 Beth Israel Medical Center - Petrie Division
 Peter Kozuch Ph: 212-844-6286
 St. Luke's - Roosevelt Hospital Center - St.Luke's Division
 Peter Kozuch Ph: 212-844-6286
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Christopher H Chay Ph: 828-213-4150
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Angela T Alistar Ph: 336-713-6771
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward J. Wos Ph: 701-323-5760
  Email: tfischer@mohs.org
Ohio
  Canton
 Aultman Cancer Center at Aultman Hospital
 Kisa E Weeman Ph: 330-363-6891
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Tanios Bekaii-Saab Ph: 866-627-7616
  Email: osu@emergingmed.com
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Carla Kurkjian Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Eliot Lawrence Friedman Ph: 610-402-2273
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Bradley W Lash Ph: 800-836-0388
Rhode Island
  Providence
 Roger Williams Medical Center
 Ponnandai S Somasundar Ph: 401-456-2268
  Email: rdavies@rwmc.org
South Carolina
  Anderson
 AnMed Cancer Center
 Charles E Bowers Ph: 800-486-5941
 Charles E Bowers Ph: 800-486-5941
  Greenville
 Bon Secours St. Francis Health System
 Charles E Bowers Ph: 800-486-5941
  Greer
 Gibbs Cancer Center-Pelham
 Charles E Bowers Ph: 800-486-5941
  Spartanburg
 CCOP - Upstate Carolina
 Charles E Bowers Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Charles E Bowers Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
Tennessee
  Nashville
 MBCCOP - Meharry Medical College - Nashville
 John J Murray Ph: 615-327-5724
  Email: jmurray@mmc.edu
Texas
  Amarillo
 Harrington Cancer Center
 Stewart Allen Sharp Ph: 806-359-4673
  Email: ryokubaitis@harringtoncc.org
Vermont
  White River Junction
 Veterans Affairs Medical Center - White River Junction
 Nancy B Kuemmerle
  Email: calgbco@calgb.org
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 Yoshio Inoue Ph: 253-403-2394
  Bellevue
 Overlake Cancer Center at Overlake Hospital Medical Center
 Yoshio Inoue Ph: 253-403-2394
  Centralia
 Providence Centralia Hospital
 Yoshio Inoue Ph: 253-403-2394
  Everett
 Providence Regional Cancer Partnership
 Yoshio Inoue Ph: 253-403-2394
  Federal Way
 St. Francis Hospital
 Yoshio Inoue Ph: 253-403-2394
  Lacey
 Western Washington Oncology, Incorporated, PS at Western Washington Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  Olympia
 Capital Medical Center
 Yoshio Inoue Ph: 253-403-2394
 Providence St. Peter Hospital Regional Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  Puyallup
 Good Samaritan Cancer Center
 Yoshio Inoue Ph: 253-403-2394
  Tacoma
 Allenmore Hospital
 Yoshio Inoue Ph: 253-403-2394
 CCOP - Northwest
 Yoshio Inoue Ph: 253-403-2394
 Franciscan Cancer Center at St. Joseph Medical Center
 Yoshio Inoue Ph: 253-403-2394
 MultiCare Regional Cancer Center at Tacoma General Hospital
 Yoshio Inoue Ph: 253-403-2394
 Northwest Medical Specialties, PLLC - Tacoma
 Yoshio Inoue Ph: 253-403-2394
 St. Clare Hospital
 Yoshio Inoue Ph: 253-403-2394
Wisconsin
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  New Richmond
 Cancer Center of Western Wisconsin
 Patrick J. Flynn Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01015833
ClinicalTrials.gov processed this data on February 19, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.