Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00222469|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 9, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: bevacizumab Drug: gemcitabine Drug: oxaliplatin||Phase 2|
- 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.
- 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.
- Approximately 30 patients will be enrolled to the study between the University of Oklahoma and M.D. Anderson Cancer Center.
- The study will be conducted over approximately 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
3-agent treatment group
10mg/kg IV on Day 1 Q 2 weeks
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
100mg/m2 on Day 2 and Q 2 weeks.
- To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin [ Time Frame: One year ]
- To determine the objective tumor response rate in this patient population. To determine time to progression (TTP) and progression free survival (PFS) in this patient population [ Time Frame: One year ]
- To determine the tolerability and toxicity profile of this regimen in this patient population [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222469
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Mehrdad Jafari, MD, PhD||University of Oklahoma|