Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484939
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2007-06-11
Brief Title:
A Study of Bevacizumab Avastin in Combination With Capecitabine Xeloda in Elderly Patients With Metastatic Colorectal Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomised Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2015-01
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 2-arm study assessed the efficacy and safety of bevacizumab Avastin in combination with capecitabine Xeloda compared with capecitabine alone in elderly patients with metastatic colorectal cancer Patients were randomized to receive either bevacizumab 75 mgkg intravenously on Day 1 of each 3-week cycle in combination with capecitabine 1000 mgm2 orally twice a day on Days 1-14 of each 3-week cycle or capecitabine 1000 mgm2 orally twice a day on Days 1-14 of each 3-week cycle alone
No notable trends or interactions in laboratory values electrocardiogram or vital signs suggesting an effect in either direction for capecitabinebevacizumab combination therapy or capecitabine monotherapy were observed during the study
No notable trends or interactions in laboratory values electrocardiogram or vital signs suggesting an effect in either direction for capecitabinebevacizumab combination therapy or capecitabine monotherapy were observed during the study
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