OBJECTIVES:
Primary
* Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.
Secondary
* Compare the time of response in patients treated with these regimens.
* Compare the clinical benefit of and tolerance to these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.
After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.
Quality of life is assessed at baseline and then every 2 months.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.
