Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 11:58 AM
Study NCT ID:
NCT00123851
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2005-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tarceva, Capecitabine and Oxaliplatin for Metastatic Colorectal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is designed to investigate the safety, tolerability and the effectiveness when OSI-774 (tarceva) is combined with oxaliplatin and capecitabine in treating patients with metastatic colorectal cancer.
Detailed Description:
Patients will be treated with OSI-774 (orally) daily, oxaliplatin (intravenously) every 3 weeks, and capecitabine (orally) twice daily for 14 days followed by a 7-day rest period. This will constitute a 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: