Fixed Dose Rate Infusion Research Articles

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

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...

A combination of a fixed dose rate infusion of gemcitabine associated to a bolus 5-fluorouracil in advanced pancreatic cancer, a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD)

Laboratory evidences suggest the possibility that an infusion rate of 10 mg/m2/min may be more effective than the standard 30-min infusion of Gemcitabine (GEM). Thirty-four patients with histologically verified locally unresectable and/or metastatic pancreatic carcinoma received GEM at the dose of 1,500 mg/m2 with an infusion rate of 10 mg/m2/min, associated to 5-fluorouracil (5-FU) at the dose of 600 mg/m2. Both drugs were administered weekly for two consecutive weeks out of every three weeks. One complete and five partial responses have been observed for an overall response rate of 17% (95% CI: 3%-27%). The time to progression was 3.7 months with a median survival of 5.7 months. A clinical benefit was obtained in 5 of 29 patients (17%). Grade 3-4 WHO toxicities included neutropenia (35%) and thrombocytopenia (10%). It is unlikely that a fixed dose rate infusion of GEM, at least with this dose, can improve palliation in comparison with the standard 30-min infusion schedule in advanced pancreatic cancer.