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Status:

TERMINATED

Sorafenib in Treating Patients With Locally Advanced or Metastatic Liver Cancer and Cirrhosis

Lead Sponsor:

UNC Lineberger Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Liver Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Sorafenib 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. PURPOSE: This phase I trial is studying the sid...

Detailed Description

OBJECTIVES: Primary * To evaluate the pharmacokinetic parameters of sorafenib tosylate in patients with locally advanced or metastatic hepatocellular carcinoma and Child-Pugh B cirrhosis. * To corre...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of hepatocellular carcinoma (HCC) according to tissue histology\* NOTE: \*Recurrence of previously resected HCC does not require tissue confirmation if there is clear radiographic recurrence, in the opinion of the investigator
  • Locally advanced or metastatic disease OR not eligible for surgical resection or immediate liver transplantation
  • Child-Pugh class B cirrhosis
  • Moderate hepatic dysfunction (bilirubin ≤ 3 times upper limit of normal \[ULN\]) OR severe hepatic dysfunction (bilirubin \> 3 times but ≤ 6 times ULN)
  • No known brain metastasis unless the metastasis has been stable for \> 3 months
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Life expectancy \> 12 weeks
  • Hemoglobin \> 9.0 g/dL
  • ANC \> 1,000/mm\^3
  • Platelet count \> 45,000/mm\^3
  • ALT and AST \< 7 times ULN
  • INR \< 2.0
  • Creatinine \< 1.7 times ULN OR creatinine clearance \> 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study treatment
  • No history of uncontrolled seizures, CNS disorders, or psychiatric disability that, in the opinion of the investigator, is clinically significant, precludes giving informed consent, or interferes with compliance of oral drug intake
  • No other concurrent active malignancy
  • No active clinically serious infection \> CTCAE grade 2
  • No known hypersensitivity to sorafenib tosylate or to any of the excipients
  • No known or suspected allergy to sorafenib tosylate or to any agent given in the course of this study
  • No NYHA class III or IV congestive heart failure
  • No unstable angina
  • No new onset angina (i.e., within the past 3 months)
  • No myocardial infarction within the past 6 months
  • No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management
  • No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • No pulmonary hemorrhage/bleeding event \> CTCAE grade 2 within the past 4 weeks
  • No other hemorrhage/bleeding event \> CTCAE grade 3 within the past 4 weeks
  • No variceal bleeding within the past 90 days
  • No known grade 2 or 3 esophageal varices
  • No evidence or history of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 4 weeks
  • No serious non-healing wound, ulcer, or bone fracture
  • No other serious uncontrolled medical condition (e.g., uncontrolled ascites or encephalopathy) that, in the opinion of the investigator, may compromise study participation
  • No condition that would impair the patient's ability to swallow whole pills
  • No malabsorption problem
  • No active drug or alcohol abuse
  • PRIOR CONCURRENT THERAPY:
  • No more than one prior therapy including, but not limited to, any of the following:
  • Systemic chemotherapy
  • Hepatic artery infusion of chemotherapy
  • Chemoembolization
  • Radioembolization
  • Ablation
  • At least 4 weeks since prior embolization, resection, or ablation
  • No prior RAF/MEK/ERK-targeting therapy or VEGF-targeting therapy
  • More than 4 weeks since prior participation in an investigational drug study
  • More than 4 weeks since prior major surgery or open biopsy
  • No concurrent chronic anticoagulation other than 1 mg of warfarin per day for central venous catheter patency
  • No concurrent St. John's wort or rifampin

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2010

    Estimated Enrollment :

    6 Patients enrolled

    Trial Details

    Trial ID

    NCT00767468

    Start Date

    October 1 2008

    End Date

    November 1 2010

    Last Update

    May 23 2012

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States, 27599-7295

    2

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710