NCT00222469

Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-09-22
• Last updated: 2008-07-09

Locations

2 sites across 1 country: United States