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Sponsors and Collaborators: |
University of Oklahoma Genentech Sanofi-Aventis M.D. Anderson Cancer Center |
Information provided by: | University of Oklahoma |
ClinicalTrials.gov Identifier: | NCT00222469 |
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 | Intervention | Phase |
Metastatic Pancreatic Cancer |
Drug: bevacizumab Drug: gemcitabine Drug: oxaliplatin |
Phase II |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Bevacizumab Oxaliplatin |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer |
Enrollment: | 50 |
Study Start Date: | August 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
3-agent treatment group
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Drug: bevacizumab
10mg/kg IV on Day 1 Q 2 weeks
Drug: gemcitabine
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
Drug: oxaliplatin
100mg/m2 on Day 2 and Q 2 weeks.
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Design:
Purpose:
Enrollment:
Duration:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Uncontrolled intercurrent illness including:
United States, Oklahoma | |||||
University of Oklahoma | |||||
Oklahoma City, Oklahoma, United States, 73104 | |||||
United States, Texas | |||||
MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030 |
University of Oklahoma |
Genentech |
Sanofi-Aventis |
M.D. Anderson Cancer Center |
Principal Investigator: | Mehrdad Jafari, MD, PhD | University of Oklahoma |
Responsible Party: | University of Oklahoma Dept. of Medicine ( Mehrdad Jafari, MD ) |
Study ID Numbers: | 2004-0652 |
First Received: | September 20, 2005 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00222469 |
Health Authority: | United States: Food and Drug Administration |
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