Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors

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)