title: Combining gemcitabine, oxaliplatin and capecitabine (GEMOXEL) for patients with advanced pancreatic carcinoma (APC): a phase I/II trial.
abstract: BACKGROUND
  Gemcitabine remains the mainstay of palliative treatment of advanced pancreatic carcinoma (APC). Adding capecitabine or a platinum derivative each significantly prolonged survival in recent meta-analyses. The purpose of this study was to determine dose, safety and preliminary efficacy of a first-line regimen combining all three classes of active cytotoxic drugs in APC.
  
  
  METHODS
  Chemotherapy-naive patients with locally advanced or metastatic, histologically proven adenocarcinoma of the pancreas were treated with a 21-day regimen of gemcitabine [1000 mg/m² day (d) 1, d8], escalating doses of oxaliplatin (80-130 mg/m² d1) and capecitabine (650-800 mg/m² b.i.d. d1-d14). The recommended dose (RD), determined in the phase I part of the study by interpatient dose escalation in cohorts of three to six patients, was further studied in a two-stage phase II part with the primary end point of response rate by RECIST criteria.
  
  
  RESULTS
  Forty-five patients were treated with a total of 203 treatment cycles. Thrombocytopenia and diarrhea were the toxic effects limiting the dose to an RD of gemcitabine 1000 mg/m² d1, d8; oxaliplatin 130 mg/m² d1 and capecitabine 650 mg/m² b.i.d. d1-14. Central independent radiological review showed partial remissions in 41% [95% confidence interval (CI) 26% to 56%] of patients and disease stabilization in 37% (95% CI 22% to 52%) of patients.
  
  
  CONCLUSIONS
  This triple combination is feasible and, by far, met the predefined efficacy criteria warranting further investigations.
authors.affiliation: Departments of Medical Oncology. Electronic address: vhess@uhbs.ch.
authors.forename: V
authors.initials: V
authors.lastname: Hess
authors.affiliation: Departments of Medical Oncology.
authors.forename: S
authors.initials: S
authors.lastname: Pratsch
authors.affiliation: Departments of Radiology, University Hospital Basel.
authors.forename: S
authors.initials: S
authors.lastname: Potthast
authors.affiliation: Departments of Medical Oncology.
authors.forename: L
authors.initials: L
authors.lastname: Lee
authors.affiliation: Department of Medical Oncology, Cantonal Hospital Lucerne.
authors.forename: R
authors.initials: R
authors.lastname: Winterhalder
authors.affiliation: Onkozentrum Hirslanden, Zurich.
authors.forename: L
authors.initials: L
authors.lastname: Widmer
authors.affiliation: Department of Medical Oncology, St Clara Hospital Basel.
authors.forename: C
authors.initials: C
authors.lastname: Cescato
authors.affiliation: Department of Medical Oncology, Cantonal Hospital Liestal.
authors.forename: A
authors.initials: A
authors.lastname: Lohri
authors.affiliation: Department of Medical Oncology, Cantonal Hospital Bruderholz.
authors.forename: L
authors.initials: L
authors.lastname: Jost
authors.affiliation: Departments of Medical Oncology.
authors.forename: P
authors.initials: P
authors.lastname: Stillhart
authors.affiliation: Department of Medical Oncology, University Hospital Zurich, Switzerland.
authors.forename: B
authors.initials: B
authors.lastname: Pestalozzi
authors.affiliation: Departments of Medical Oncology.
authors.forename: R
authors.initials: R
authors.lastname: Herrmann
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine