Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116506
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2005-06-29
Brief Title:
Study of Bevacizumab Erlotinib FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Bevacizumab Avastin and Erlotinib Tarceva in Combination With FOLFOX for Patients With Untreated Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Despite recent advances most patients with advanced colorectal cancer continue to have a poor prognosis 5-FU leucovorin oxaliplatin and bevacizumab is a standard treatment option for patients with stage IV colorectal cancer Fluorouracil 5-FU leucovorin and oxaliplatin are considered traditional chemotherapies that try to stop tumor growth by affecting how they divide Bevacizumab is a therapy to try to block the blood vessels that tumors need to grow It is considered a targeted agent Erlotinib is another targeted agent that has been shown to be effective in treating lung and other cancers This trial is assessing the potential benefit of adding these second targeted agents to standard treatment
Detailed Description:
Patients receive bevacizumab oxaliplatin leucovorin and 5-FU intravenously The erlotinib is taken orally each day One cycle of study therapy is 14 days Cycles may be repeated unless there are intolerable side effects or the cancer worsens
Patients will undergo a tumor measurement evaluation following 3 cycles of study therapy and then every 4 cycles thereafter
Patients will undergo a tumor measurement evaluation following 3 cycles of study therapy and then every 4 cycles thereafter
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