Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101686
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2005-01-12
Brief Title:
Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine Infusional 5-FU FOLFIRI Modified-Bolus 5-FU Day 1 8 And Oral Capecitabine Day 1-14 With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23 2004 To Include Bevacizumab
Status:
COMPLETED
Status Verified Date:
2010-01
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:
This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine ie infusion bolus and oral In the second period of study it compares FOLFIRI a chemotherapy regime that combines bolus irinotecan and leucovorin LV with infusional 5-fluorouracil 5-FU bevacizumab and mlFL bevacizumab Measures of efficacy and safety will be reported
Detailed Description:
None
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 |
|---|---|---|---|
| A5961021 | None | None | None |