PHASE I STUDY OF BIWEEKLY GEMCITABINE FOLLOWED BY OXALIPLATIN AND SIMPLIFIED 48-H INFUSION OF FLUOROURACIL/LEUCOVORIN FOR ADVANCED PANCREATIC CANCER
Resource
J GASTROENTEROL HEPATOL v.21 n.5 pp.874-879
Journal
J GASTROENTEROL HEPATOL
Journal Volume
v.21
Journal Issue
n.5
Pages
874-879
Date Issued
2006
Date
2006
Author(s)
CHANG, HUI-JU
WANG, CHUAN-CHENG
CHENG, ANN-LII
Abstract
Objectives: To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5-FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer. Patients and Methods: Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed-rate infusion (10 mg/m(2)/minute) of 800 mg/m(2) gemcitabine followed by 2-h infusion of oxaliplatin and then 48-h infusion of 5-FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m(2). Results: A total of 15 patients were enrolled at three dose levels. Dose-limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/ m(2) and 85 mg/m(2), respectively. The MTD of oxaliplatin for this combination was 85 mg/m(2). After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7% of patients and thrombocytopenia in 13.3%. Non- hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3 %, 95% confidence interval, 6.3-60.4%). Conclusion: Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m(2).
SDGs
Type
journal article