Abstract
PURPOSE: This phase II study was conducted to assess the efficacy of fluorodeoxyuridine (FUdR) in patients with metastatic, advanced pancreatic cancer who had no previous chemotherapy. PATIENTS AND METHODS: Twenty patients were enrolled in this single institution trial. The primary endpoint of this study was the assessment of overall survivorship. The secondary endpoints were to estimate the time to tumor progression and the assessment of toxicity in this cohort of patients. Treatment consisted of FUdR 150 mg/kg dissolved in 500 cc normal saline intravenous infusion over 24 h. Eight weeks of treatment constituted one course of chemotherapy. Tumor measurements were conducted at 8-weekly intervals. RESULTS: Four patients achieved partial response and 16 patients had stable disease. Median survival of patients treated with FUdR was 11.6 months with a range of 3-16 months. Median progression-free survival was 6 months. Overall, chemotherapy was well tolerated with low incidence of grade 3 or 4 toxicity. CONCLUSIONS: Systemic chemotherapy with high dose FUdR administered on a weekly schedule has led to encouraging survival outcomes and improved quality of life as compared to previous phase II single agent chemotherapeutic trials.