Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

Fecha de inicio: 1 de noviembre de 2003

DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic adenocarcinoma * Locally advanced or metastatic disease * Unresectable disease * Measurable disease * At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner * No adenocarcinoma of the bile ducts or ampulla of Vater * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin less than 1.5 times normal * Alkaline phosphatase less than 5 times normal Renal * Creatinine less than 1.5 times normal * No uncontrolled or persistent hypercalcemia Cardiovascular * No serious cardiac failure Pulmonary * No serious respiratory failure Other * Pain must be stabilized or controlled before initiation of study treatment * Not pregnant or nursing * Fertile patients must use effective contraception * No other untreatable malignant tumor * No serious psychological, familial, social, or geographical condition that would preclude study participation * No neuropathy that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * No concurrent corticosteroids except for antiemetic therapy Radiotherapy * No prior radiotherapy Surgery * Not specified