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