Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353262
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2006-07-17
Brief Title:
A Study of Xeloda Capecitabine in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-02
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 single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin and assess whether the pharmacokinetics of Xeloda andor oxaliplatin is influenced by the addition of Avastin All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda 1000mgm2 bid and oxaliplatin 130mgm2 iv and in cycle 3 Avastin 75mgkg iv will be added to the regimen The anticipated time on study treatment is 3-12 months and the target sample size is 100 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