DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct, meeting all of the following criteria:

  • Locally advanced or metastatic disease
  • Unresectable disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

  • Tumor that recurs within a previously irradiated field is considered measurable disease if recurrence is documented and measurable by RECIST criteria
• Tumor must be Her2/neu positive by FISH testing
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 40,000/mm³
• Bilirubin ≤ 4 mg/dL
• AST and ALT ≤ 5 times upper limit of normal (ULN)
• Creatinine ≤ 2 times ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to, during, and for ≥ 3 months after completion of study treatment
• No other active malignancy
• LVEF ≥ 50%

• No concurrent uncontrolled illness, including, but not limited to, any of the following:

  • Ongoing or active infection requiring systemic IV antibiotics on day 1 of treatment
  • Symptomatic New York Heart Association class III-IV congestive heart failure
  • Unstable angina pectoris
  • Unstable cardiac arrhythmia requiring medication
• -

PRIOR CONCURRENT THERAPY:

• Prior surgery and radiotherapy allowed
• No more than 1 prior systemic chemotherapy regimen
• At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered

• No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal therapy

  • Concurrent hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed

• No concurrent corticosteroids or anticonvulsants

  • Concurrent steroids administered for antiemesis, adrenal failure, or septic shock allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients