NCT00154791

Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma

Phase I/II Trial of Biweekly Gemcitabine, Oxaliplatin, and 48-Hour Infusion of High-Dose 5-FU/Leucovorin (GOFL) in Advanced Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (planned)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We plan to conduct a phase I/II clinical trial using biweekly gemcitabine, oxaliplatin, and 48-hour infusion of high dose 5-FU/leucovorin to treat patients with advanced pancreatic adenocarcinoma. In the phase I part, the maximum tolerable dose of oxaliplatin in combination with biweekly gemcitabine 800 mg/m2 and 48-hour infusion of 5-FU 3000 mg/m2 and leucovorin 300 mg/m2 will be determined. In the phase II part, the efficacy and safety of the biweekly chemotherapy with GOFL will be evaluated.

Detailed description

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	oxaliplatin
DRUG	gemcitabine
DRUG	5-FU/LV

Timeline

• Start date: 2003-03-01
• Completion: 2005-08-01
• First posted: 2005-09-12
• Last updated: 2005-09-12

Locations

1 site across 1 country: Taiwan