Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064181
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2003-07-08
Brief Title:
Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Irinotecan Combined With Infusional 5-FUFolinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 such as irinotecan capecitabine leucovorin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor It is not yet known which combination chemotherapy regimen with or without celecoxib is more effective in treating metastatic colorectal cancer
PURPOSE This randomized phase III trial is studying two combination chemotherapy regimens and celecoxib to see how well they work compared to two combination chemotherapy regimens alone in treating patients with metastatic colorectal cancer
PURPOSE This randomized phase III trial is studying two combination chemotherapy regimens and celecoxib to see how well they work compared to two combination chemotherapy regimens alone in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Compare the progression-free survival of patients with metastatic colorectal cancer treated with capecitabine and irinotecan vs fluorouracil leucovorin calcium and irinotecan with vs without celecoxib
Compare the safety of these regimens in these patients
Compare the response rate in patients treated with these regimens
Compare the time to treatment failure and overall survival of patients treated with these regimens
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center prior adjuvant therapy yes vs no and risk group poor vs intermediate vs good Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive irinotecan IV over 30-90 minutes on days 1 and 22 oral capecitabine twice daily on days 1-15 and 22-36 and oral celecoxib twice daily on days 1-42
Arm II Patients receive irinotecan and capecitabine as in arm I and oral placebo twice daily on days 1-42
Arm III Patients receive irinotecan IV over 30-90 minutes on days 1 15 and 29 leucovorin calcium CF IV over 2 hours and fluorouracil 5-FU IV over 22 hours on days 1 2 15 16 29 and 30 and oral celecoxib twice daily on days 1-42
Arm IV Patients receive irinotecan CF and 5-FU as in arm III and oral placebo twice daily on days 1-42
In all arms treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity If all chemotherapy is discontinued due to toxicity patients may continue celecoxib or placebo until disease progression unacceptable toxicity or starting a new cytotoxic regimen
NOTE The double-blind treatment only applies to the celecoxib and placebo randomization
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 692 patients 173 per treatment arm will be accrued for this study within 35 years
Compare the progression-free survival of patients with metastatic colorectal cancer treated with capecitabine and irinotecan vs fluorouracil leucovorin calcium and irinotecan with vs without celecoxib
Compare the safety of these regimens in these patients
Compare the response rate in patients treated with these regimens
Compare the time to treatment failure and overall survival of patients treated with these regimens
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center prior adjuvant therapy yes vs no and risk group poor vs intermediate vs good Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive irinotecan IV over 30-90 minutes on days 1 and 22 oral capecitabine twice daily on days 1-15 and 22-36 and oral celecoxib twice daily on days 1-42
Arm II Patients receive irinotecan and capecitabine as in arm I and oral placebo twice daily on days 1-42
Arm III Patients receive irinotecan IV over 30-90 minutes on days 1 15 and 29 leucovorin calcium CF IV over 2 hours and fluorouracil 5-FU IV over 22 hours on days 1 2 15 16 29 and 30 and oral celecoxib twice daily on days 1-42
Arm IV Patients receive irinotecan CF and 5-FU as in arm III and oral placebo twice daily on days 1-42
In all arms treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity If all chemotherapy is discontinued due to toxicity patients may continue celecoxib or placebo until disease progression unacceptable toxicity or starting a new cytotoxic regimen
NOTE The double-blind treatment only applies to the celecoxib and placebo randomization
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 692 patients 173 per treatment arm will be accrued for this study within 35 years
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 |
|---|---|---|---|
| EORTC-40015 | None | None | None |