Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant

NCT00844168 | Completed Phase 1 DMC

• 2 other identifiers: 6697NCI-2009-01659
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after liver transplant may be an effective treatment for liver cancer

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Resectable Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT) as defined by the Common Terminology for Adverse Events (CTAE) version 3

  Defined as grade \>= 3 nonhematologic/hematologic toxicity

  28 days

Study Arms (1)

Treatment (adjuvant sorafenib tosylate after liver transplant)

EXPERIMENTAL

Patients receive sorafenib tosylate PO twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: sorafenib tosylate; Other: laboratory biomarker analysis

Interventions

sorafenib tosylate DRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Treatment (adjuvant sorafenib tosylate after liver transplant)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (adjuvant sorafenib tosylate after liver transplant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Edward Lin

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

US (1)