Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Diagnosis of adenocarcinoma of the pancreas

  • Locally advanced or metastatic disease
• Measurable disease, defined as at least 1 lesion measurable by RECIST criteria

Exclusion criteria:

• Brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status 0-2
• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Creatinine < 1.5 times normal
• Transaminases < 2 times normal (5 times normal if liver metastases)
• Total bilirubin < 1.5 times normal
• Fertile patients must use effective contraception

Exclusion criteria:

• Pregnant or nursing
• Intestinal occlusion
• Prior inflammatory intestinal disease
• Crohn's disease
• Hemorrhagic rectal colitis
• Peripheral neuropathy > grade 2

• Other severe illness, including any of the following:

  • Unstable cardiac disease, even if treated
  • Psychological or neurological disease including dementia
  • Uncontrolled active infection
  • Other severe illness that would compromise study participation
• Impossible to receive study therapy due to geographical, social, or psychological reasons
• Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics
• At least 6 months since prior chemotherapy or radiochemotherapy
• At least 4 weeks since prior radiotherapy and/or surgery

Exclusion criteria:

• Prior therapy for advanced disease
• Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase)
• Prior inhibitors of angiogenesis (e.g., bevacizumab)
• Prior organ graft or allogeneic transplantation
• Prior extensive intestinal resection
• Concurrent participation in another therapeutic study
• Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin)