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