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

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