Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the pancreas Locally advanced or metastatic disease Locally advanced disease must extend outside the boundaries of a standard radiotherapy port Not amenable to curative surgery or radiotherapy Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Pleural effusion and ascites are not considered measurable lesions Outside prior radiotherapy port No known brain metastases Performance status - ECOG 0-1 Performance status - Karnofsky 70-100% More than 3 months WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No evidence of bleeding diathesis Bilirubin normal AST and/or ALT ≤ 2.5 times upper limit of normal Creatinine normal Creatinine clearance ≥ 60 mL/min No uncontrolled hypertension No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active or ongoing infection No other active malignancy No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No prior antiangiogenic agents No prior cytotoxic chemotherapy for metastatic disease At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior gemcitabine See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior investigational drugs No prior sorafenib No prior MAPK signaling agents Concurrent warfarin anticoagulation allowed provided the following criteria are met: Therapeutic on a stable warfarin dose INR ≤ 3 Undergo weekly INR testing No active bleeding or pathological condition that carries a high risk of bleeding No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapies