Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024427
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2001-09-13
Brief Title:
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Wellstat Therapeutics
Organization:
Wellstat Therapeutics
Study Overview
Official Title:
An Open Label Randomized Controlled Phase III Multi-center Clinical Trial Of PN401 With High Dose 5-Fluorouracil 5FU Versus Gemcitabine For Treatment Of Patients With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2010-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving the drugs in different combinations may kill more tumor cells Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy It is not yet known which chemotherapy regimen is more effective in treating pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil plus triacetyluridine with that of gemcitabine in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery
Detailed Description:
OBJECTIVES
Compare the survival of patients with unresectable locally advanced or metastatic pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs gemcitabine
Compare the time to tumor progression overall response rate and response duration in patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease stage II or III vs IV Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive high-dose fluorouracil 5-FU IV over 30 minutes once weekly on weeks 1-3 followed by 1 week of rest After each dose of 5-FU patients receive oral triacetyluridine every 8 hours for a total of 8 doses Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 followed by 1 week of rest course 1 Subsequent courses are given on weeks 1-3 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 260 patients 130 per treatment arm will be accrued for this study within 30 months
Compare the survival of patients with unresectable locally advanced or metastatic pancreatic cancer treated with triacetyluridine and high-dose fluorouracil vs gemcitabine
Compare the time to tumor progression overall response rate and response duration in patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to disease stage II or III vs IV Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive high-dose fluorouracil 5-FU IV over 30 minutes once weekly on weeks 1-3 followed by 1 week of rest After each dose of 5-FU patients receive oral triacetyluridine every 8 hours for a total of 8 doses Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 followed by 1 week of rest course 1 Subsequent courses are given on weeks 1-3 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 260 patients 130 per treatment arm will be accrued for this study within 30 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-F010524008 | None | None | None |
| WELLSTAT-40100001 | None | None | None |
| PRONEURON-40100001 | None | None | None |
| UAB-0105 | None | None | None |