Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 17, 2009
Trial Information
Current as of June 24, 2025
Completed
Keywords
ClinConnect Summary
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 patient...
Gender
ALL
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 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)
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Lebanon, New Hampshire, United States
Seattle, Washington, United States
Saint Louis, Missouri, United States
Flint, Michigan, United States
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Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Kingsport, Tennessee, United States
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Dublin, California, United States
Lone Tree, Colorado, United States
Mishawaka, Indiana, United States
Ames, Iowa, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Metairie, Louisiana, United States
Hattiesburg, Mississippi, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Auburn, New York, United States
Syracuse, New York, United States
Pleasant Hill, California, United States
Iowa City, Iowa, United States
Jonesboro, Arkansas, United States
Clovis, California, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
Houma, Louisiana, United States
Reno, Nevada, United States
Reno, Nevada, United States
Asheville, North Carolina, United States
Brevard, North Carolina, United States
Franklin, North Carolina, United States
Jacksonville, North Carolina, United States
Marion, North Carolina, United States
Spruce Pine, North Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Lancaster, South Carolina, United States
Rock Hill, South Carolina, United States
Gig Harbor, Washington, United States
Bronx, New York, United States
Bainbridge Island, Washington, United States
Federal Way, Washington, United States
Gig Harbor, Washington, United States
Kennewick, Washington, United States
Lynnwood, Washington, United States
Poulsbo, Washington, United States
Puyallup, Washington, United States
Tacoma, Washington, United States
Tacoma, Washington, United States
Asheville, North Carolina, United States
Mukwonago, Wisconsin, United States
White River Junction, Vermont, United States
Washington, District Of Columbia, United States
Mobile, Alabama, United States
Liverpool, New York, United States
Rome, New York, United States
Clinton, North Carolina, United States
El Paso, Texas, United States
Springfield, Ohio, United States
Patients applied
Trial Officials
Ghassan K Abou-Alfa
Principal Investigator
Alliance for Clinical Trials in Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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