title: Gemcitabine-capecitabine plus intra-arterial epirubicin-cisplatin in pretreated pancreatic cancer patients: a phase I study.
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Oncology, Carrara city Hospital, piazza Sacco e Vanzetti, 54033 Carrara (MS), Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Mambrini
authors.forename: Paola
authors.initials: P
authors.lastname: Pacetti
authors.forename: Alfonso
authors.initials: A
authors.lastname: Del Freo
authors.forename: Roberta Della
authors.initials: RD
authors.lastname: Seta
authors.forename: Debora
authors.initials: D
authors.lastname: Pezzuolo
authors.forename: Tito
authors.initials: T
authors.lastname: Torri
authors.forename: Massimo
authors.initials: M
authors.lastname: Orlandi
authors.forename: Roberta
authors.initials: R
authors.lastname: Tartarini
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cantore
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007261:Infusions, Intra-Arterial; D020714:Maximum Tolerated Dose; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine