Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)
Full description
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a phase I, dose escalation study followed by a randomized phase II study.
Phase I (closed to accrual as of 11/03/2010): Patients receive oral sorafenib tosylate twice daily on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Phase II: Patients are stratified according to gender (female vs male), ECOG performance status (0 vs 1), and Child-Pugh class (A vs B7). Patients are randomized to 1 of 2 treatment arms.
Blood samples are collected periodically for analysis of circulating endothelial cells and circulating endothelial progenitor cells and angiogenic proteins in plasma by ELISA.
After completion of study treatment, patients are followed for 3 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular carcinoma
Measurable disease
No mixed cholangiocarcinoma/hepatocellular carcinoma
No current or previously resected brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy ≥ 3 months
ANC ≥ 1,200/mm³
Platelet count ≥ 75,000/mm³
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 5 times ULN
Alkaline phosphatase ≤ 5 times ULN
Urine protein ≤ 1+ by urine protein:creatinine ratio OR 24-hour urine protein < 1 g
QTc interval ≤ 500 msec on baseline EKG
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 2 weeks after sorafenib tosylate and 6 months after bevacizumab
None of the following risk factors for decreased LVEF:
No uncontrolled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) despite optimal medical management
No New York Heart Association class III-IV congestive heart failure
No cardiac ventricular arrhythmias requiring antiarrhythmic therapy
No history of hypertensive crisis or hypertensive encephalopathy
No cardiac ventricular arrhythmia requiring anti-arrhythmic therapy within the past 6 months
None of the following within the past 6 months:
No active or recent history of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
No evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation)
No significant traumatic injury within the past 4 weeks
No serious or non-healing wound, ulcer, or bone fracture
No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
No other active malignancy within the past 3 years, except nonmelanotic skin cancer or carcinoma in situ of the cervix
No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or sorafenib tosylate
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal