Continuum Cancer Center

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Title:	Update of a phase I-II study of biweekly irinotecan in combination with gemcitabine (G), 5FU (F), leucovorin (LV) and cisplatin (G-GLIP) in patients with metastatic pancreatic cancer
Author(s):	A. Goel, S. Malamud, M. Grossbard, P. Homel, M. Dietrich, P. Kozuch, T. Mirzoyev
Lay Summary:	This abstract reflects the Continuum Cancer Centers Of New York commitment to improving the lives of people affected by metastatic pancreatic cancer. Throughout this decade we have offered patients access to the most innovative therapy available but encouraging their participation in clinical trials. One such trial involves a novel combination of existing drugs, the so-called G-FLIP regimen consisting of sequential gemcitabine, 5-fluorouracil, irinotecan and cisplatin given over two days in our outpatient infusion suites. This regimen was well tolerated and was associated with favorable response and survival outcomes.
Background:	Development of systemic therapy to improve outcomes associated with gemcitabine for metastatic pancreatic cancer remains a research priority. The GFLIP regimen was designed to maximize sequence dependent synergy while attempting to minimize toxicity among the four drugs.
Methods:	The dose limiting toxicities and maximum tolerated dose of irinotecan as part of the G-FLIP regimen have been published. For phase II testing GFLIP consisted of sequential gemcitabine (500mg/m2) at a fixed rate of 10 mg/m2/minute, irinotecan (120 mg/m2), bolus 5-FU (400mg/m2) and LV (300mg) followed by a 24 hour 5-FU infusion (1500mg/m2) on day 1, followed by cisplatin (35mg/m2) on Day 2. Cycles were repeated every 14 days. Thirty one patients with metastatic pancreatic carcinoma treated on phase I/II trial are evaluable for toxicity and activity update.
Toxicity:	Treatment was generally well tolerated. Grade 3-4 toxicities per patient were thrombocytopenia (3.2%), leukopenia (16.1%), neutropenia (22.5%), neutropenic fever (3.2%), fatigue (19.3%) and thrombosis (12%). Common Grade 1-2 toxicities were nausea /vomiting (71%), diarrhea (45%), constipation (22%) and fatigue (42%).
Conclusions:	G-FLIP is a novel and feasible outpatient regimen with acceptable toxicity in metastatic pancreatic cancer. Phase III evaluation should be considered if the encouraging survival outcomes are maintained.