Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer
PRIMARY OBJECTIVES: I. To evaluate the objective response rate (complete response \[CR\] + partial response \[PR\]) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria in each group of patients. SECONDARY OBJECTIVES: I. To evaluate the progression free survival at 6 months. II. To evaluate the toxicity profile of this treatment in each group of patients. III. To evaluate median overall survival, 6 and 12 months survival rates. IV. To assess target-epidermal growth factor receptor (EGFR)/EGFR-P protein expression and the genes that regulate the cell cycle and apoptosis, which are either downstream of or cross-talk with the EGFR signaling pathway, to explore their association with clinical outcome. V. To measure expression profile and mutations of genes critical for EGFR and (v-erb-b2 erythroblastic leukemia viral oncogene homolog 2 (ERBB2 signaling pathways with particular relevance to GW572016, and to explore new gene-drug relationships as relating to hepatocellular and biliary carcinomas. OUTLINE: This is a multicenter study. Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Correlative studies
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST
PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.
Time frame: Up to 3 years
Progression-free Survival
Time frame: up to 6 months
Toxicity Profile Assessed Using NCI CTCAE Version 3.0
Percentage of patients with Adverse events accordng to NCI CTCAE version 3.0
Time frame: Up to 3 years
Median Overall Survival
Time frame: Up to 3 years
Overall Survival
Time frame: up to 12.6 months
Target-EGFR/EGFR-P Protein Expression
EGFR (exons 18-21)
Time frame: Up to 3 years
Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways
Time frame: Up to 3 years
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