Abstract
4112 Background: It has seen suggested that the FDR infusion of gemcitabine increases intracellular triphosphate gemcitabine, which in turn may achieve a higher treatment benefit compared to the standard infusion. Combination gemcitabine and irinotecan may have additive or synergistic effects with few or no overlapping toxicities. Methods: A open-label phase I dose escalation trial is designed to evaluate the safety of combination FDR infusion gemcitabine and irinotecan in advanced/metastatic pancreatic and biliary cancer. The primary end points are to find the dose for phase II study, dose limiting toxicity (DLT), and maximum tolerable dose (MTD). The response of the combination will also be determined for patients with measurable or evaluable diseases. Gemcitabine is infused intravenously at a FDR of 10 mg/m2/min, and the infusion time is based on the dose level. Irinotecan is administered intravenously over 60 min after gemcitabine. Both gemcitabine and irinotecan are given on day 1 & 8 of a 21-day cycle. The dose-escalation schedule is listed in table 1. Results: Nineteen pts have been entered to date (median age 60, [23–73], mean PS 1). No DLT was observed in 3 pts enrolled at dose level 1. 1 of 7 pts developed DLT (Gr 4 neutropenia & Gr 3 thrombocytopenia) at dose level 2. 1 of 8 pts experienced dose-limiting Gr 4 neutropenia at dose level 3. Non-hematologic toxicities are mild to moderate, including Gr 1–2 nausea/vomiting, diarrhea and fatigue. 2 patients developed DVT during the treatment. Of 17 evaluable pts, there have been 4 partial responses (PR), and 9 pts have maintained stable disease (SD) (8 of these 9 pts have had ≥ 6 cycles of treatment). 2 pts with advanced pancreatic cancer, after 22 cycles of the combination chemotherapy, are still on therapy. Conclusions: The study is on-going at dose level 4. No MTD has been reached. The combination is tolerable and encouraging Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Pfizer Pfizer Pfizer
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