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Clinical Trials (PDQ®)

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

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2011-01981
ECOG-E1208, CDR0000657952, E1208, U10CA021115, U10CA180820, NCT01004978

Trial Description

Summary

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.

Further Study Information

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 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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Jean-Francois (Jeff) GeschwindPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Carla I. Falkson Ph: 205-934-0309
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Rangaswamy Govindarajan Ph: 501-686-8274
California
  Greenbrae
 Marin Cancer Institute at Marin General Hospital
 Peter D. Eisenberg Ph: 415-925-5000
  Email: info@marinspecialtycare.com
  Los Angeles
 USC/Norris Comprehensive Cancer Center and Hospital
 Anthony Boutros El-Khoueiry Ph: 323-865-0451
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Alan Paul Venook Ph: 877-827-3222
  Stanford
 Stanford Cancer Center
 Daniel Y Sze Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-4673
  New Haven
 Yale Cancer Center
 Stacey M Stein Ph: 203-785-5702
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Paul G. Montgomery Ph: 800-845-4624
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
  Fruitland
 Saint Luke's Mountain States Tumor Institute - Fruitland
 Paul G. Montgomery Ph: 800-845-4624
  Meridian
 Mountain States Tumor Institute - Meridian
 Paul G. Montgomery Ph: 800-845-4624
  Nampa
 Saint Luke's Mountain States Tumor Institute
 Paul G. Montgomery Ph: 800-845-4624
  Twin Falls
 Mountain States Tumor Institute at St. Luke's
 Paul G. Montgomery Ph: 800-845-4624
Illinois
  Bloomington
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  La Grange
 La Grange Memorial Hospital
 Renee H. Jacobs Ph: 630-856-7526
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
Kansas
  Hays
 Hays Medical Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Kansas City
 Kansas City Cancer Centers - West
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Overland Park
 Kansas City Cancer Centers - Southwest
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Pittsburg
 Mount Carmel Regional Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Salina
 Tammy Walker Cancer Center at Salina Regional Health Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Shawnee Mission
 Kansas City Cancer Center - Shawnee Mission
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Topeka
 St. Francis Comprehensive Cancer Center
 Peter J. VanVeldhuizen Ph: 800-525-1483
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 John J Rinehart Ph: 859-257-3379
Louisiana
  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
 Tufts Medical Center Cancer Center
 Kevin P Daly Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Jean-Francois (Jeff) H Geschwind Ph: 410-955-8804
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-4673
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-4673
Missouri
  Kansas City
 Kansas City Cancer Centers - North
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Kansas City Cancer Centers - South
 Peter J. VanVeldhuizen Ph: 800-525-1483
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: aroland@kccop.org
 Truman Medical Center - Hospital Hill
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Lee's Summit
 Kansas City Cancer Centers - East
 Peter J. VanVeldhuizen Ph: 800-525-1483
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Benjamin R Tan Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nevada
  Reno
 Renown Institute for Cancer at Renown Regional Medical Center
 Christos A Galanopoulos Ph: 775-982-4400
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Cheryl A Carlson Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
Ohio
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Anjali S Advani Ph: 866-223-8100
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce J. Averbook Ph: 216-778-8526
  Email: kbauchens@metrohealth.org
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Carl R Schmidt Ph: 866-627-7616
  Email: osu@emergingmed.com
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Shubham Pant Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Shubham Pant Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Edward J Gorak Ph: 570-271-5251
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Crystal S Denlinger Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Ashwin R Sama Ph: 215-955-6084
South Carolina
  Anderson
 AnMed Cancer Center
 Charles E Bowers Ph: 800-486-5941
 Charles E Bowers Ph: 800-486-5941
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Melanie B Thomas Ph: 843-792-9321
  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
Texas
  Amarillo
 Harrington Cancer Center
 Stewart Allen Sharp Ph: 806-359-4673
  Email: ryokubaitis@harringtoncc.org
Virginia
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Andrew Poklepovic Ph: 804-628-1939
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 John A Keech Ph: 253-887-9333
  Centralia
 Providence Centralia Hospital
 John A Keech Ph: 253-887-9333
  Everett
 Providence Regional Cancer Partnership
 John A Keech Ph: 253-887-9333
  Lakewood
 St. Clare Hospital
 John A Keech Ph: 253-887-9333
  Puyallup
 Good Samaritan Cancer Center
 John A Keech Ph: 253-887-9333
  Seattle
 CCOP - Virginia Mason Research Center
 Craig R. Nichols Ph: 503-215-6412
  Tacoma
 MultiCare Regional Cancer Center at Tacoma General Hospital
 John A Keech Ph: 253-887-9333
West Virginia
  Morgantown
 Mary Babb Randolph Cancer Center at West Virginia University Hospitals
 Brent T Steadman Ph: 304-293-2745
  Email: sfilburn@hsc.wvu.edu
Wisconsin
  Marshfield
 Marshfield Clinic - Marshfield Center
 Kristin M. Gerndt Ph: 715-389-4457
  Milwaukee
 Froedtert Hospital and Medical College of Wisconsin
 Lauren A Wiebe Ph: 414-805-4380

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01004978
ClinicalTrials.gov processed this data on October 16, 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.

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