Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449163
Status:
TERMINATED
Last Update Posted:
2017-05-11
First Post:
2007-03-15
Brief Title:
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Phase II Study of Avastin Irinotecan High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by University of Miami Institutional Review Board
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as irinotecan floxuridine and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor Giving combination chemotherapy together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer
Detailed Description:
For the purpose of this study treatment cycle consist of six weeks 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest Treatment will be administered weekly 4 out 6 weeks on days 1 8 22 and 29 according to the schedule There will be no treatment delivered on weeks 3 6 Days 15 and 36
Disease will be evaluated by CT scan at the completion of every two cycles Patients with complete response CR or partial response PR will be evaluated for possible surgical resection Patients who become operable will continue to be evaluated for survival and disease relapse Patients with stable disease SD and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects
Disease will be evaluated by CT scan at the completion of every two cycles Patients with complete response CR or partial response PR will be evaluated for possible surgical resection Patients who become operable will continue to be evaluated for survival and disease relapse Patients with stable disease SD and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB-20060252 | OTHER | Western Institutional Review Board | None |
| SCCC-2005145 | OTHER | None | None |