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

You may be eligible if

• 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