 The primary end point of the study is time to tumor progression. The study is designed to detect increase in median time to tumor progression from 2.7 months to 4.0 months, with 80 power at a significance level of 5. This requires approximately 100 patients. The median time to tumor progression of 2.7 months was found in the Investigational New Drug IND treatment program for gemcitabine, which enrolled 3023 patients with locally advanced or metastatic colon cance 