Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290615
Status:
COMPLETED
Last Update Posted:
2013-05-07
First Post:
2006-02-09
Brief Title:
Capecitabine Cetuximab Oxaliplatin and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery
Sponsor:
Herbert Hurwitz
Organization:
Duke University
Study Overview
Official Title:
Phase II Study of Oxaliplatin Capecitabine Cetuximab and Bevacizumab in the Treatment of Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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 Giving more than one drug combination chemotherapy may kill more tumor cells Monoclonal antibodies such as cetuximab and 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 Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving capecitabine together with cetuximab oxaliplatin and bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving capecitabine together with cetuximab oxaliplatin and bevacizumab works in treating patients with metastatic or recurrent colorectal cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving capecitabine together with cetuximab oxaliplatin and bevacizumab works in treating patients with metastatic or recurrent colorectal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with unresectable metastatic or recurrent colorectal adenocarcinoma treated with capecitabine cetuximab oxaliplatin and bevacizumab
Secondary
Determine the safety and tolerability of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Exploratory
Determine the effect of this regimen on the angiogenesis biomarkers in these patients
Determine the effect of this regimen on wound angiogenesis in these patients
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 Patients will also receive cetuximab IV over 1-2 hours oxaliplatin IV over 2 hours and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 1 month
PROJECTED ACCRUAL Approximately 45 patients will be accrued for this study
Primary
Determine the response rate in patients with unresectable metastatic or recurrent colorectal adenocarcinoma treated with capecitabine cetuximab oxaliplatin and bevacizumab
Secondary
Determine the safety and tolerability of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Exploratory
Determine the effect of this regimen on the angiogenesis biomarkers in these patients
Determine the effect of this regimen on wound angiogenesis in these patients
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 Patients will also receive cetuximab IV over 1-2 hours oxaliplatin IV over 2 hours and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 1 month
PROJECTED ACCRUAL Approximately 45 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 |
|---|---|---|---|
| DUMC-7118-05-4R0 | None | None | None |