RATIONALE: Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer.

OBJECTIVES:

• Determine the progression-free rate at 24 weeks in patients with unresectable hepatocellular or biliary carcinoma treated with erlotinib.
• Determine the toxicity profile of this drug in these patients.
• Determine the objective response rate in patients treated with this drug.
• Determine the overall and progression-free survival of patients treated with this drug.
• Correlate epidermal growth factor receptor protein levels with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary).

Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 78 patients (39 per group) will be accrued for this study within 13 months.

• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Liver Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed hepatocellular or biliary carcinoma

  • Unresectable disease
  • Noninvasive diagnosis of unresectable hepatocellular carcinoma by hypervascular mass on CT scan and alpha fetoprotein greater than 100 ng/mL allowed

• Measurable disease

  • At least 1 lesion with diameter at least 2.0 cm

  • Indicator lesions must be outside of prior treatment area and edges of lesions must be clearly distinct

    • Patients whose sole indicator lesion is inside prior treatment area are eligible provided the lesion shows clear evidence of disease progression
• Child-Pugh classification A or B
• No ampulla of Vater tumors
• No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 75,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 3 times ULN
• INR no greater than 1.5 (for patients not receiving anticoagulation)
• Albumin at least 2.5 g/dL

Renal:

• Creatinine no greater than 2 mg/dL

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal:

• No requirement for IV alimentation
• No gastrointestinal tract disease resulting in an inability to take oral medication
• No active peptic ulcer disease

Ophthalmic:

• No known abnormalities of the cornea including, but not limited to, the following:

  • 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 or Bengal-Rose)
  • Abnormal corneal sensitivity test (Schirmer test or similar tear production test)

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No significant traumatic injury within the past 3 weeks
• No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma of the cervix
• No ongoing or active infection
• No concurrent uncontrolled medical or psychiatric illness or social situation that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• More than 4 weeks since prior immunotherapy or biologic therapy
• No concurrent immunotherapy

Chemotherapy:

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No more than 1 prior systemic anticancer therapy

  • Chemoembolization considered 1 prior chemotherapeutic regimen
• No concurrent chemotherapy

Endocrine therapy:

• No concurrent anti-cancer hormonal agents

Radiotherapy:

• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy (including whole brain irradiation for documented CNS metastasis)

Surgery:

• More than 3 weeks since prior major surgery
• More than 6 weeks since prior cryotherapy

Other:

• Recovered from prior therapy
• More than 6 weeks since prior radiofrequency ablation, ethanol injection, or photodynamic therapy
• No prior epidermal growth factor receptor-targeting therapy
• No prior procedures affecting absorption
• No concurrent combination anti-retroviral therapy for HIV-positive patients
• No other concurrent investigational therapy or supportive care
• No other concurrent anticancer medications