Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004233
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2000-01-28
Brief Title:
S9915 Triacetyluridine Fluorouracil and Leucovorin in Treating Patients With Unresectable Locally Advanced or Metastatic Cancer of the Esophagus or Stomach
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study of PN-401 5-FU and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach
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 Chemoprotective drugs such as triacetyluridine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of triacetyluridine fluorouracil and leucovorin in treating patients who have unresectable locally advanced or metastatic cancer of the esophagus or stomach
PURPOSE Phase II trial to study the effectiveness of triacetyluridine fluorouracil and leucovorin in treating patients who have unresectable locally advanced or metastatic cancer of the esophagus or stomach
Detailed Description:
OBJECTIVES
Assess the 6-month survival rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine fluorouracil and leucovorin calcium
Evaluate the qualitative and quantitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1 8 15 22 29 and 36 Patients receive oral triacetyluridine every 8 hours on days 1-3 8-10 15-17 22-24 29-31 and 36-38 beginning 8 hours after completion of each fluorouracil infusion Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 53 patients will be accrued for this study
Assess the 6-month survival rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with triacetyluridine fluorouracil and leucovorin calcium
Evaluate the qualitative and quantitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 30 minutes beginning 1 hour into leucovorin calcium infusion on days 1 8 15 22 29 and 36 Patients receive oral triacetyluridine every 8 hours on days 1-3 8-10 15-17 22-24 29-31 and 36-38 beginning 8 hours after completion of each fluorouracil infusion Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 53 patients will be accrued for this study
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 |
|---|---|---|---|
| S9915 | OTHER | SWOG | None |
| CA32102 | OTHER_GRANT | None | None |