A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine As First-Line Therapy Of Patients With Advanced Pancreas Cancer

Fecha de inicio: 1 de enero de 2004

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