Results of a phase I study of fixed dose rate gemcitabine /irinotecan (FIGI)

Abstract

2112 Background: Based on the activity of combined gemcitabine (gem)/ irinotecan (irino), we performed a phase I/PK study using Fixed Dose Rate (FDR) Infusion gem. The primary objectives were DLT and RPTD of irino combined with FDR Infusion gem at 10mg/m2/min(FIGI). Secondary objectives included the evaluation of antitumor activity as well as the PK and pharmacodynamic interaction of this combination. Methods: Pts with advanced cancer, adequate organ function, and PS of 0–1 were eligible. Gem and irino were given on days 1 and 8 q21d according to the dose levels below. Gem was infused over the time noted. Pts were followed with weekly CBC's and CT scans q 2 cycles. Results: 17 pts with, med age 54 (34–67 yrs), and med 1 prior regimen were enrolled, including 6 pancreatic, 4 gastric/GEJ, 3 colorectal and 1 pt each with anal, cholangio, esophageal, and primary peritoneal carcinoma. All are evaluable for toxicity, 16 for response. 1 pt at DL4 is currently being treated. The MTD and RPTD have not yet been rea...