Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Inclusion Criteria

• •Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma
• •* No ampullary carcinoma
• •Locally advanced unresectable or distant metastatic disease
• •Measurable disease
• •Patients with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage
• •No prior systemic treatment for metastatic or unresectable locally advanced disease
• •No known brain metastases
• •Zubrod performance status of 0-1
• •Leukocyte count ≥ 3,000/mm\^3
• •ANC ≥ 1,000/mm\^3
• •Platelet count ≥100,000/mm\^3
• •Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •* For patient who had decompression of the biliary tree within the past 14 days, stability of the bilirubin level needs to be confirmed with two measurements within 5 to 7 days of each other
• •Serum albumin ≥ 2.5 g/dL
• •AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
• •Creatinine clearance ≥ 60 mL/min
• •Not pregnant or nursing
• •Fertile patients must agree to use effective contraception
• •No active biliary sepsis
• •No bleeding diathesis
• •No uncontrolled or clinically significant cardiovascular disease, including any of the following:
• •* Myocardial infarction within the past 6 months
• •* Uncontrolled angina within the past 6 months
• •* NYHA class II-IV congestive heart failure
• •* Grade 3 cardiac valve dysfunction
• •* Cardiac arrhythmia not controlled by medication
• •* History of stroke or transient ischemic attack within the past 6 months
• •* History of arterial thrombotic event of any type in the past 6 months
• •No uncontrolled hypertension, as evidenced by systolic BP ≥ 150 mm Hg or diastolic BP ≥ 100 mm Hg, within the past 28 days
• •Must be able to swallow and tolerate oral medications
• •* No gastrointestinal tract disease or prior abdominal surgery that results in an inability to absorb oral medication
• •No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free within the past 3 years
• •No concurrent grapefruit or its juice
• •At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal therapy, immunotherapy, radiotherapy (to \< 25% of bone marrow only), or chemoradiotherapy before documented recurrence or metastatic disease
• •No prior treatment with any antiangiogenic agent or any EGFR inhibitors for any reason
• •Concurrent multiple anti-hypertensive medications allowed
• •No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other therapy, including herbal or alternative medications for treatment of cancer