Phase I/II Trial of Biweekly Gemcitabine, Oxaliplatin, and 48-Hour Infusion of High-Dose 5-FU/Leucovorin (GOFL) in Advanced Pancreatic Adenocarcinoma
For each dose of GOFL chemotherapy, intravenous infusion of gemcitabine at a fixed rate of
10 mg/m2/min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin
and then a 48-hour intravenous infusion of 5-FU and leucovorin.The starting dose of
oxaliplatin in the phase I part is 65 mg/m2, with dose increment of 10 mg/m2. Since the
recommended dose for biweekly single dose oxaliplatin is 85 mg/m2, there will be no further
dose escalation of oxaliplatin beyond 85 mg/m2.Patients will be entered in cohorts of
three.If one out of three patients develops DLT, three additional patients will be accrued
to the same dose level.9.1.3 The six patients treated at the MTD dose level will be included
in the phase II part of this study if only they have measurable lesion(s) prior to
chemotherapy.For the phase II part, If three or more responders are observed in the initial
21 evaluable patients, the trial will proceed to the second stage. Additional 24 patients
will be accrued in the second stage of the phase II part.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary objective: to evaluate the maximum tolerated dose of oxaliplatin in phase I part and to evaluate the objective tumor response rate of GOFL in phase II part
Li-Tzong Chen, M.D.Ph.D
Study Chair
National Health Research Institutes, Division of Cancer Research
Taiwan: Department of Health
900905
NCT00154791
March 2003
August 2005
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