Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • Locally advanced, unresectable disease, defined by all of the following:

    • Obvious encasement of the celiac, hepatic, or superior mesenteric artery
    • Encasement of the portal or superior mesenteric vein not amenable to surgical resection
    • Extrapancreatic extension with or without regional lymph node involvement
    • No evidence of distant metastatic disease by staging laparoscopy*

  • Locally recurrent disease after prior curative surgery allowed provided the following are true:

    • No prior chemotherapy or radiotherapy
    • No evidence of distant metastatic disease by staging laparoscopy*
• No islet cell pancreatic cancer or lymphoma or sarcoma of the pancreas

• Measurable or evaluable disease

  • Primary pancreatic tumor is considered evaluable and not measurable disease
  • Lymph node mass considered measurable disease
• No known brain metastases
• Performance status - ECOG 0-2
• More than 12 weeks
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Bilirubin ≤ 1.5 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine ≤ 2.0 mg/dL
• Creatinine clearance ≥ 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
• No Crohn's disease or inflammatory bowel disease that would preclude undergoing external beam radiotherapy
• Able to tolerate oral medication
• No requirement for IV alimentation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No ongoing or active infection
• No other concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance
• See Disease Characteristics
• No prior gemcitabine
• See Disease Characteristics
• See Disease Characteristics
• No prior epidermal growth factor receptor-targeting therapy
• No prior therapy for pancreatic cancer (except surgery)
• No concurrent commercial or other investigational agents or therapies intended to treat the malignancy
• No concurrent combination antiretroviral therapy for HIV-positive patients