Gemcitabine-Capecitabine plus Intra-arterial Epirubicin-Cisplatin in Pretreated Pancreatic Cancer Patients: A Phase I Study

Background: Gemcitabine plus capecitabine are active in patients (pts) with advanced pancreatic cancer (APC). Intra-arterial chemotherapy showed activity and low toxicity. Combination of systemic and intra-arterial chemotherapy was investigated. Patients and Methods: Patients with APC, progressed after a first-line chemotherapy, were included. Fixed doses of epirubicin 35 mg/m 2 and cisplatin 42 mg/m 2 intra-arterially every 28 days, and capecitabine 650 mg/m 2 twice a day on days 2-15; gemcitabine systemically in increasing doses on day 2. The purpose was to find maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT). Results: Fifteen patients were enrolled. DLT occurred at 1300 mg/m 2 of gemcitabine and consisted of myelotoxicity (grade 4 febrile neutropenia and grade 4 thrombocytopenia). Conclusion: Limiting toxicity was hematological. For further studies intra-arterial epirubicin 35 mg/m 2 and cisplatin 42 mg/m 2 ; systemic gemcitabine at 1,000 mg/m 2 on day 2, and capecitabine at 650 mg/m 2 twice a day PO on days 2-15 are suggested.