Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

Inclusion Criteria: Histologically confirmed diagnosis of 1 of the following: Hepatocellular carcinoma (hepatoma) Child-Pugh classification score ≤ 7 Biliary tract carcinoma Surgically unresectable disease Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Fresh tissue or paraffin embedded tissue from tumor blocks available No ampulla of Vater tumors No known brain metastases Performance status - ECOG 0-1 Performance status - Karnofsky 60-100% More than 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 75,000/mm^3 Bilirubin ≤ 2 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN Albumin ≥ 2.5 mg/dL INR ≤ 1.5 (for patients not receiving an anticoagulant) Live metastases or stable chronic liver disease allowed No current active hepatic or biliary disease except for Gilbert's syndrome or asymptomatic gallstone Creatinine ≤ 2 mg/dL Ejection fraction normal by echocardiogram or MUGA No unstable angina pectoris No cardiac arrhythmia Able to swallow and retain oral medication No gastrointestinal (GI) tract disease resulting in an inability to take oral medication No malabsorption syndrome No requirement for IV alimentation No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant traumatic injury within the past 3 weeks No active or ongoing infection No history of allergic reaction attributed to compounds of similar chemical or biological composition to lapatinib No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix More than 4 weeks since prior biologic therapy More than 4 weeks since prior immunotherapy See Radiotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No prior cumulative doxorubicin dose > 450 mg/m^2 At least 14 days since prior and no concurrent glucocorticoids (e.g., dexamethasone or equivalent [dose > 1.5 mg/day]) More than 4 weeks since prior radiotherapy More than 12 weeks since prior radiotherapy with or without a fluoropyrimidine as a radiosensitizer (for patients with biliary carcinoma only) No prior surgical procedure affecting absorption More than 3 weeks since prior major surgery Recovered from all prior therapy No more than 1 prior systemic anticancer therapy, including chemoembolization No prior epidermal growth factor receptor-targeting therapy More than 6 weeks since prior cryotherapy, radiofrequency ablation, ethanol injection, transarterial chemoembolization, or photodynamic therapy AND meets both of the following criteria: Indicator lesion is outside the area of prior treatment OR there is clear evidence of disease progression associated with the sole indicator lesion Edges of indicator lesion are clearly distinct by CT scan At least 7 days since prior and no concurrent H2 inhibitors or proton pump inhibitors Concurrent antacids allowed provided they are administered > 1 hour before and > 1 hour after study drug administration At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: Clarithromycin Erythromycin Troleandomycin Delaviridine Ritonavir Indinavir Saquinavir Nelfinavir Amprenavir Lopinavir Itraconazole Ketoconazole Voriconazole Fluconazole (doses ≤ 150 mg/day are allowed) Nefazodone Fluvoxamine Verapamil Diltiazem Cimetidine Aprepitant Grapefruit and grapefruit juice Bitter orange At least 6 months since prior and no concurrent amiodarone At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following: Phenytoin Carbamazepine Phenobarbital Oxcarbazepine Efavirenz Nevirapine Rifampin Rifabutin Rifapentine Roxithromycin Telithromycin Hypericum perforatum (St. John's wort) Modafinil No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy Concurrent oral anticoagulants (e.g., coumadin or warfarin) allowed provided there is increased vigilance in monitoring INR