A phase II trial of 5-fluorouracil, leucovorin, and interferon alpha 2A (IFN-alpha 2a) in metastatic pancreatic carcinoma - A Penn Cancer Clinical Trials Group (PCCTG) trial

A phase II study was performed to evaluate the activity and toxicity of 5-f luorouracil (5-FU), leucovorin, and inteferon alpha-2a in metastatic pancre atic carcinoma. Twenty-three patients were entered in this study. Four pati ents withdrew before receiving treatment and one patient was nonevaluable f or response because of treatment-related toxicity. The most common signific ant toxicity was nausea and vomiting. Treatment-related hospitalization was significant. Of 18 evaluable patients, 4 maintained stable disease and 14 had disease progression. None had an objective clinical response. We conclu de that this biochemically modulated 5-FU regimen is ineffective treatment for advanced pancreatic carcinoma, with significant toxicity even in highly selected patients with an ambulatory performance status.