Status:
COMPLETED
Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of sorafenib tosylate in treating patients with liver cancer who have undergone a liver transplant. Sorafenib tosylate may stop the growth of ...
Detailed Description
PRIMARY OBJECTIVES: I. Establish the safety and toxicity profile of sorafenib administered daily to hepatocellular carcinoma (HCC) patients who have undergone orthotopic liver transplantation. SECON...
Eligibility Criteria
Inclusion
- Patients with HCC on explant, who have not received prior systemic anti-cancer treatment for HCC
- HCC patients who have undergone orthotopic liver transplantation, are at high risk for tumor recurrence or who have high suspicion or documentation of tumor recurrence
- Patients who have a life expectancy of at least 12 weeks
- Patients must have one of the following disease states:
- Patients are 4 weeks beyond and less than 60 days from liver transplant surgery (to first study treatment) who have no residual hepatocellular carcinoma following liver transplantation;
- Patients with post transplant recurrent hepatocellular carcinoma within the liver or at an extra hepatic site, diagnosed by radiographic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) consistent with hepatocellular carcinoma or proved by biopsy, within 24 months of transplantation;
- Post-transplant patients with rising alpha-feta protein level \> 500ng/mL, even in the absence of confirmed disease within 24 months of transplant
- Patients must have one of the following explant histological features of HCC:bilobar tumor; macrovascular invasion; or multifocality; if patients have well-differentiated HCC, they must have all three features
- Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Platelet count \>= 60 x 10\^9/L
- Hemoglobin \>= 8.5 g/dL
- Total bilirubin =\< 3 mg/dL
- Alanine transaminase (ALT) and aspartate transaminase (AST) =\< 5 x upper limit of normal
- Amylase and lipase =\< 1.5 x the upper limit of normal
- Serum creatinine =\< 1.5 x the upper limit of normal
- Prothrombin time (PT)-international normalized ratio (INR) =\< 2.3 or PT 6seconds above control
- Patients who give written informed consent
Exclusion
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma,superficial bladder tumors (Ta, Tis \& T1); any cancer curatively treated \> 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- History of cardiac disease: congestive heart failure \> New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers ordigoxin; or uncontrolled hypertension; myocardial infarction more than 6months prior to study entry is permitted
- Active clinically serious infections \> grade 2 (National Cancer Institute -Common Terminology Criteria for Adverse Events version 3.0)
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Known or suspected allergy to the investigational agent or any agent given in association with this trial
- Patients unable to swallow oral medications
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients; women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
- Prior use of any systemic anti-cancer chemotherapy for HCC
- Prior use of systemic investigational agents for HCC
- Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or Farnesyl transferase inhibitors
- Use of biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 3 weeks prior to study entry (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the discretion of the investigator; however, they may not be substituted for a required dose reduction)
- Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 1 month prior to the study or during the study
- Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
- Concomitant treatment with rifampin and St John's wort
- Concomitant anti-coagulation therapy with warfarin
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00844168
Start Date
January 1 2009
Last Update
March 27 2015
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109