Inclusion Criteria

Criteria:

- Absolute neutrophil count >= 1,500/mm3

- Histologically or cytologically confirmed cholangiocarcinoma or gallbladder
carcinoma:

- Metastatic or surgically unresectable disease

- Measurable disease, defined as >= 1 lesion whose longest diameter can be accurately
measured as >= 2.0 cm with conventional techniques or as > 1.0 cm with spiral CT
scan:

- Spiral CT scan imaging must be used for pre- and post-treatment tumor
measurements of lesions measuring >= 1.0 cm to < 2.0 cm

- Clinical lesions will only be considered measurable when they are superficial

- Lesions on chest x-ray are acceptable as measurable lesions when they are
clearly defined and surrounded by aerated lung

- No ampulla of Vater tumors

- No evidence of CNS disease

- Life expectancy >= 3 months

- ECOG performance status 0-2

- Platelet count >= 75,000/mm3

- Total bilirubin =< 2 times ULN

- ALT and AST =< 2.5 times ULN

- Creatinine =< 2 mg/dL

- Albumin >= 2.5 g/dL

- Alkaline phosphatase =< 5 times ULN

- Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1000 mg

- No concurrent illness or medical condition, including any of the following:

- Impairment of gastrointestinal (GI) function or disease that may significantly
alter the absorption of erlotinib hydrochloride

- Requirement for IV alimentation

- No concurrent illness or medical condition, including any of the following:

- Active peptic ulcer disease;

- Serious or nonhealing wound, ulcer, or bone fracture;

- GI bleed that required procedural intervention within the past 3 months

- No concurrent illness or medical condition, including any of the following:

- Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28
days

- Ongoing or active infection

- Symptomatic congestive heart failure

- Psychiatric illness or social situation that would limit study compliance

- No other malignancy within the past 3 years

- No abnormalities of the cornea

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No clinically significant cardiovascular disease

- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas
or mitomycin C) and recovered

- No significant traumatic injury within the past 28 days

- No prior systemic anticancer therapy for metastatic gallbladder or bile duct cancer

- More than 28 days since prior major surgery [Note: Insertion of a vascular access
device is not considered major/minor surgery]

- More than 2 weeks since prior minor surgery [Note: Insertion of a vascular access
device is not considered major/minor surgery]

- More than 7 days since prior core biopsy

- No concurrent major surgery

- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy
or supportive care considered investigational

- No concurrent enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer, such
as rifampin or Hypericum perforatum

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents or other concurrent anticancer therapies

- No concurrent prophylactic hematopoietic colony-stimulating factors

- Concurrent full-dose anticoagulants allowed provided PT/INR is > 1.5 and both of the
following criteria are met:

- In-range INR on a stable dose of oral anticoagulant OR on a stable dose of low
molecular weight heparin

- AND (continued from above) No active bleeding or pathological condition that carries
a high risk of bleeding (e.g., tumor involving major vessels, gastrointestinal
ulcerations, or known varices)