Bevacizumab and Erlotinib in Treating Patients With Advanced Liver Cancer
Completed · Phase 2
Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
In brief
This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with advanced liver cancer. 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells
Key facts
- Study ID
- NCT00365391
- Run by
- National Cancer Institute (NCI)
- People needed
- 27
- Starts
- 2006-08-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2015-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Absolute neutrophil count >= 1,500/mm\^3
- Creatinine =< 2 mg/dL
- Albumin >= 2.5 g/dL
- Total bilirubin =< upper limit of normal (ULN)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN
- Alkaline phosphatase =< 5 times ULN
- Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg
- Not pregnant or nursing:
- No nursing for >= 6 months after completion of study treatment
- Negative pregnancy test
- Fertile patients must use effective contraception during study and for >= 6 months after completion of study treatment
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab or erlotinib hydrochloride
- No abnormalities of the cornea, including any of the following:
- History of dry eye syndrome or Sjögren's syndrome; Congenital abnormality (e.g., Fuch's dystrophy); Abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose); Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
- No stroke or transient ischemic attack within the past 6 months
- No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- No unstable angina pectoris within the past 6 months
- No symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmias
- No uncontrolled diabetes mellitus
- No active or uncontrolled infection
- No impaired GI function or disease that may significantly alter the absorption of erlotinib hydrochloride (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or bowel obstruction)
- Able to swallow tablets
- No psychiatric illness or social situation that would limit compliance with study requirements
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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