Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084721
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2004-06-10
Brief Title:
Irinotecan and Celecoxib in Treating Patients With Unresectable or Metastatic Colorectal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study of Irinotecan in Combination With Fixed Dose Celecoxib in Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 work in different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving irinotecan with celecoxib may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan when given with celecoxib in treating patients with unresectable or metastatic colorectal cancer
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan when given with celecoxib in treating patients with unresectable or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of irinotecan when administered with celecoxib in patients with unresectable or metastatic colorectal cancer
Secondary
Determine the dose-limiting toxic effects and non-dose-limiting toxic effects of this regimen in these patients
Determine the incidence and intensity of diarrhea and myelotoxicity in patients treated with this regimen
Determine any responses in patients treated with this regimen
Determine potential mechanisms for irinotecan-induced diarrhea and protective effects of celecoxib on diarrhea prevention in patients treated with this regimen
OUTLINE This is a dose-escalation study of irinotecan Patients are assigned to 1 of 2 treatment groups
Group I Patients receive a fixed dose of irinotecan IV over 90 minutes on days 1 8 15 and 22 and oral celecoxib twice daily on days 10-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Group II Patients receive irinotecan as in group I at escalating doses and oral celecoxib twice daily on days 0-42 Treatment continues as in group I
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 18-30 patients 9 for group I 9-21 for group II will be accrued for this study within 1-2 years
Primary
Determine the maximum tolerated dose of irinotecan when administered with celecoxib in patients with unresectable or metastatic colorectal cancer
Secondary
Determine the dose-limiting toxic effects and non-dose-limiting toxic effects of this regimen in these patients
Determine the incidence and intensity of diarrhea and myelotoxicity in patients treated with this regimen
Determine any responses in patients treated with this regimen
Determine potential mechanisms for irinotecan-induced diarrhea and protective effects of celecoxib on diarrhea prevention in patients treated with this regimen
OUTLINE This is a dose-escalation study of irinotecan Patients are assigned to 1 of 2 treatment groups
Group I Patients receive a fixed dose of irinotecan IV over 90 minutes on days 1 8 15 and 22 and oral celecoxib twice daily on days 10-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Group II Patients receive irinotecan as in group I at escalating doses and oral celecoxib twice daily on days 0-42 Treatment continues as in group I
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 18-30 patients 9 for group I 9-21 for group II will be accrued for this study within 1-2 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 |
|---|---|---|---|
| RPCI-RP-0224 | None | None | None |