Phase II Study of Oral L-Leucovorin,120-Hour Fluorouracil Infusion and Carboplatin in Advanced Pancreatic Cancer

Abstract

Background

No effective chemotherapy has been developed for patients with metastatic pancreatic cancer. Encouraging results have been reported with the combination of cisplatin and fluorouracil infusion. The aim of the study was to test the activity of oral L-leucovorin, carboplatin and fluorouracil infusion in untreated pancreatic cancer patients.

Patients and Methods

Patients with advanced pancreatic carcinoma were treated with carboplatin (300 mg/m² on day 1), L-leucovorin (5 mg/m² twice a day on days 1-5), and fluorouracil (1,000 mg/m² as a 120-hr infusion on days 1-5), cycles being repeated every 21 days.

Results

Nine patients were included and were assessable for response and side effects. All patients had measurable disease and an ECOG performance status of 0-2. No patient achieved partial remission, 3 had stable disease, and 6 progressive disease. Median time to progression was 2 months (range, 2-8), and median survival was 4 months (range, 3-12). Toxicity consisted of mucositis, diarrhea and neutropenia.

Conclusions

Patients with metastatic pancreatic carcinoma do not benefit from this treatment schedule.