Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-02 @ 2:50 PM
Study NCT ID:
NCT00222469
Status:
COMPLETED
Last Update Posted:
2008-07-09
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
Sponsor:
University of Oklahoma
Organization:
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 10mg/kg and gemcitabine 1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 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 M.D. Anderson Cancer Center.
Duration:
* The study will be conducted over approximately 2 years.
* A phase II single arm study. All patients receive bevacizumab 10mg/kg and gemcitabine 1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 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 M.D. Anderson Cancer Center.
Duration:
* The study will be conducted over approximately 2 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: