Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222469
Status:
COMPLETED
Last Update Posted:
2008-07-09
First Post:
2005-09-20
Brief Title:
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
A Phase II Trial of Bevacizumab Plus Gemcitabine and Oxaliplatin as First Line Therapy in Metastatic or Locally Advanced Unresectable Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2008-07
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:
The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival
In addition the study will find out what side effects patients may have by taking bevacizumab oxaliplatin and gemcitabine together
In addition the study will find out what side effects patients may have by taking bevacizumab oxaliplatin and gemcitabine together
Detailed Description:
Design
A phase II single arm study All patients receive bevacizumab 10mgkg and gemcitabine 1000mgm2 on day 1 followed by oxaliplatin 100mgm2 on day 2 of a 14 day cycle
Purpose
The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival In addition the study will find out what side effects patients may have by taking bevacizumab oxaliplatin and gemcitabine together
Enrollment
Approximately 30 patients will be enrolled to the study between the University of Oklahoma and MD Anderson Cancer Center
Duration
The study will be conducted over approximately 2 years
A phase II single arm study All patients receive bevacizumab 10mgkg and gemcitabine 1000mgm2 on day 1 followed by oxaliplatin 100mgm2 on day 2 of a 14 day cycle
Purpose
The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival In addition the study will find out what side effects patients may have by taking bevacizumab oxaliplatin and gemcitabine together
Enrollment
Approximately 30 patients will be enrolled to the study between the University of Oklahoma and MD Anderson Cancer Center
Duration
The study will be conducted over approximately 2 years
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