drugset / Trial / NCT00154791
Phase I/II Trial GOFL in Advanced Pancreatic Adenocarcinoma
Phase 1/2
Completed
45 enrolled
National Taiwan University Hospital
National Health Research Institutes, Taiwan · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2003-03
- Primary completion
- —
- Completion
- 2005-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 300 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 65 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 3000 mg/m2 | Intravenous |