Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094809
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2004-10-26
Brief Title:
Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Chemotherapy Administered Every 2 Weeks With or Without a Single Injection of Pegfilgrastim as First or Second-Line Treatment in Subjects With Locally Advanced or Metastatic Colon Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
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:
The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing grade 34 neutropenia when given after one of three chemotherapy regimens FOIL FOLFOX or FOLFIRI in patients with locally advanced or metastatic colorectal cancer This study is considered to be investigational because the time between receiving pegfilgrastim and the next cycle of chemotherapy is only 11 days
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