Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039208
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2002-06-06
Brief Title:
Combination Chemotherapy in Treating Patients With 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:
Time Finding Study of Chronomodulated Irinotecan 5 Fluorouracil Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil leucovorin and oxaliplatin in treating patients who have colorectal cancer
PURPOSE Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil leucovorin and oxaliplatin in treating patients who have colorectal cancer
Detailed Description:
OBJECTIVES
Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil leucovorin calcium and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer
Determine the antitumor activity of this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center WHO performance status 0-1 vs 2 and line of treatment first vs second Patients are randomized to receive irinotecan at 1 of 6 different times of the day
Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter
PROJECTED ACCRUAL A maximum of 186 patients 31 per irinotecan administration time will be accrued for this study within 2 years
Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil leucovorin calcium and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer
Determine the antitumor activity of this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center WHO performance status 0-1 vs 2 and line of treatment first vs second Patients are randomized to receive irinotecan at 1 of 6 different times of the day
Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter
PROJECTED ACCRUAL A maximum of 186 patients 31 per irinotecan administration time will be accrued for this study within 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 |
|---|---|---|---|
| EORTC-05011 | None | None | None |