Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026273
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2001-11-09
Brief Title:
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Multicenter Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FUFA Infusional Regimen To The Same 5-FUFA Infusional Regimen Alone As Adjuvant Treatment Of Stage III Colon Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them after surgery may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer
Detailed Description:
OBJECTIVES
Compare the disease-free survival at 3 years of patients with resected stage III colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan
Compare the disease-free and overall survival at 5 years of patients treated with these regimens
Compare the safety profiles of these treatment regimens in these patients
Compare the quality-adjusted survival of patients treated with these regimens
Correlate the expression of putative prognostic markers thymidylate synthase telomerase topoisomerase with disease-free and overall survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I
Patients receive irinotecan IV over 30-90 minutes leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours weekly for 6 weeks Courses repeat every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
As an alternative schedule patients may receive irinotecan IV over 30-90 minutes and day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 every 2 weeks for 6 weeks Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II
Patients receive leucovorin calcium and fluorouracil as in arm I Quality of life may be assessed at baseline prior to courses 2 3 and 4 and at 1 3 and 6 months
Patients are followed every 3 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 1800 patients 900 per arm will be accrued for this study within 24 months
Compare the disease-free survival at 3 years of patients with resected stage III colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan
Compare the disease-free and overall survival at 5 years of patients treated with these regimens
Compare the safety profiles of these treatment regimens in these patients
Compare the quality-adjusted survival of patients treated with these regimens
Correlate the expression of putative prognostic markers thymidylate synthase telomerase topoisomerase with disease-free and overall survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I
Patients receive irinotecan IV over 30-90 minutes leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours weekly for 6 weeks Courses repeat every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
As an alternative schedule patients may receive irinotecan IV over 30-90 minutes and day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 every 2 weeks for 6 weeks Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II
Patients receive leucovorin calcium and fluorouracil as in arm I Quality of life may be assessed at baseline prior to courses 2 3 and 4 and at 1 3 and 6 months
Patients are followed every 3 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 1800 patients 900 per arm will be accrued for this study within 24 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 |
|---|---|---|---|
| CDR0000069014 | None | None | None |
| PFIZER-A5961053 | None | None | None |
| RP-64174-V-307 | None | None | None |
| EORTC-40993 | None | None | None |
| PETACC-3 | None | None | None |