Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416494
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2006-12-27
Brief Title:
Capecitabine Oxaliplatin and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
Herbert Hurwitz MD
Organization:
Duke University
Study Overview
Official Title:
Phase II Study of Oxaliplatin Capecitabine and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2014-08
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:
RATIONALE Drugs used in chemotherapy such as capecitabine and oxaliplatin 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 find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer
PURPOSE This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine oxaliplatin and bevacizumab
Secondary
Assess time to progression TTP disease-free survival DFS and overall survival OS in patients treated with this regimen
Assess the safety and tolerability of bevacizumab oxaliplatin and capecitabine in patients with previously untreated metastatic colorectal cancer
Exploratory
Evaluate the effect of this regimen on the biomarkers of angiogenesis
Assess the effect of this regimen on wound angiogenesis
OUTLINE Patients receive oral capecitabine twice daily on days 1-5 and 8-12 oxaliplatin IV over 2 hours on day 1 and bevacizumab IV over 1-1½ hours on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Evaluate the response rate in patients with previously untreated metastatic colorectal cancer treated with capecitabine oxaliplatin and bevacizumab
Secondary
Assess time to progression TTP disease-free survival DFS and overall survival OS in patients treated with this regimen
Assess the safety and tolerability of bevacizumab oxaliplatin and capecitabine in patients with previously untreated metastatic colorectal cancer
Exploratory
Evaluate the effect of this regimen on the biomarkers of angiogenesis
Assess the effect of this regimen on wound angiogenesis
OUTLINE Patients receive oral capecitabine twice daily on days 1-5 and 8-12 oxaliplatin IV over 2 hours on day 1 and bevacizumab IV over 1-1½ hours on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000449971 | OTHER | NCI | None |
| DUMC-4951-05-7R2 | None | None | None |
| GENENTECH-DUMC-4951-05-7R2 | None | None | None |
| SANOFI-DUMC-4951-05-7R2 | None | None | None |
| ROCHE-DUMC-4951-05-7R2 | None | None | None |