S0205 Gemcitabine w/ or w/o Cetuximab as First-Line Therapy in Locally Advanced Pancreas Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically\* or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria:
• * Locally advanced unresectable disease
• * Distant metastatic disease NOTE: If diagnosis is based on a metastatic site the histology must be compatible with pancreatic cancer
• Measurable or nonmeasurable disease by x-ray, scan, or physical examination
• Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry
• None of the following tumor types are allowed:
• * Endocrine tumors
• * Lymphoma of the pancreas
• * Ampullary cancer
• No known brain metastases
• PATIENT CHARACTERISTICS:
• Age
• Not specified
• Performance status
• Zubrod 0-2
• Life expectancy
• At least 3 months
• Hematopoietic
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic
• Bilirubin no greater than 2.0 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN
• Renal
• Creatinine no greater than 2.0 mg/dL
• Cardiovascular
• No significant history of cardiac disease
• No uncontrolled hypertension
• No unstable angina
• No uncontrolled arrhythmia
• No congestive heart failure
• Other
• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in remission
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior immunotherapy for advanced pancreatic cancer
• No prior cetuximab or other therapy that targets the epidermal growth factor pathway
• No prior chimerized or murine monoclonal antibody therapy
• No other concurrent anticancer immunotherapy
• Chemotherapy
• At least 6 months since prior adjuvant chemotherapy
• No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer
• No prior gemcitabine
• No other concurrent anticancer chemotherapy
• Endocrine therapy
• No prior hormonal therapy for advanced pancreatic cancer
• No concurrent anticancer hormonal therapy
• Radiotherapy
• See Chemotherapy
• At least 28 days since prior radiotherapy and recovered
• Prior palliative radiotherapy to metastatic sites allowed
• No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis)
• Surgery
• At least 14 days since prior pancreatic cancer surgery and recovered
• Other
• No other concurrent anticancer therapy