Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069108
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2003-09-15
Brief Title:
A Study of Xeloda Capecitabine in Patients With Metastatic Colorectal Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin Q3W XELOX Versus Bolus and Continuous Infusion Fluorouracil Intravenous Leucovorin With Intravenous Oxaliplatin Q2W FOLFOX4 as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FULV as First Line Therapy
Status:
COMPLETED
Status Verified Date:
2016-03
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 2 arm study will assess the efficacy and safety of intermittent oral Xeloda or iv fluorouracilleucovorin in combination with intravenous Eloxatin oxaliplatin in patients previously treated for metastatic colorectal cancer Patients will be randomized to receive either 1XELOX Xeloda 1000mgm2 po bid on days 1-15 oxaliplatin in 3 week cycles or 2 FOLFOX-4 oxaliplatin leucovorin 5-FU in 2 week cycles The anticipated time on study treatment is until disease progression and the target sample size is 500 individuals
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