Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154791
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Phase III Trial GOFL in Advanced Pancreatic Adenocarcinoma
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Phase III Trial of Biweekly Gemcitabine Oxaliplatin and 48-Hour Infusion of High-Dose 5-FULeucovorin GOFL in Advanced Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We plan to conduct a phase III clinical trial using biweekly gemcitabine oxaliplatin and 48-hour infusion of high dose 5-FUleucovorin to treat patients with advanced pancreatic adenocarcinoma In the phase I part the maximum tolerable dose of oxaliplatin in combination with biweekly gemcitabine 800 mgm2 and 48-hour infusion of 5-FU 3000 mgm2 and leucovorin 300 mgm2 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 mgm2min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorinThe starting dose of oxaliplatin in the phase I part is 65 mgm2 with dose increment of 10 mgm2 Since the recommended dose for biweekly single dose oxaliplatin is 85 mgm2 there will be no further dose escalation of oxaliplatin beyond 85 mgm2Patients will be entered in cohorts of threeIf one out of three patients develops DLT three additional patients will be accrued to the same dose level913 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 lesions prior to chemotherapyFor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None