A phase II study of gemcitabine and 5-fluorouracil in metastatic pancreatic cancer: An Eastern Cooperative Oncology Group study (E3296)

Gemcitabine has recently been compared favorably to 5-fluorouracil (5-FU) as the standard chemotherapy for advanced pancreas cancer. Based on phase I data that combining gemcitabine with 5-FU is safe and has evidence for clinical activity, a phase II trial was conducted by the Eastern Cooperative Oncology Group (ECOG). Patients with metastatic disease, good performance status and organ function were eligible and enrolled after providing informed consent. Patients were given gemcitabine (1000 mg/m²) followed by 5-FU (600 mg/m²) weekly for 3 weeks of every 4. Of 37 patients enrolled over a 3-month period, 36 were eligible. Partial responses were seen in 5 patients (14%), Median survival was 4.4 months with a 1-year survival rate of 8.6%, A randomized trial of the combination of 5-FU and gemcitabine versus gemcitabine alone is currently accruing patients in ECOG. Copyright (C) 2000 S. Karger AG, Basel.