Biweekly irinotecan in combination with gemcitabine (G), 5-Fluorouracil (5-FU), leucovorin (LV) and cisplatin (G-FLIP) associated with encouraging activity in patients with metastatic pancreatic cancer: Update of a phase I-II trial

Abstract

4189 Background: This phase I-II study of irinotecan in combination with fixed doses of gemcitabine, 5-FU/LV and cisplatin was initiated based on encouraging clinical data with G-FLIP in the therapy of solid tumors. In this trial, G-FLIP has been modified to facilitate outpatient administration and to optimize sequence dependent synergistic activity. Patients and Methods: Phase II therapy consisted of biweekly cycles of sequential gemcitabine 500mg/m2, irinotecan 120 mg/m2, bolus 5-FU 400mg/m2 and LV 300mg on Day 1 followed by a 24 hour 5-FU infusion 1500mg/m2, followed by cisplatin 35 mg/m2 on Day 2. These doses were based on published phase I data. Eighteen patients (pts.) with biopsy confirmed metastatic pancreatic adenocarcinoma have been enrolled to date and sixteen are evaluable for response. Median pt. age was 57 years (range 41–78) and median Karnofsky performance status (KPS) was 85. Results: Pts. have received a median of 8.5 cycles (range 1–16). Sixteen pts. are eligible for evaluation followin...