Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00112528
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with gemcitabine and oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with gemcitabine and oxaliplatin works in treating patients with metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.
Secondary
* Determine the objective response rate in patients with measurable disease treated with this regimen.
* Determine median survival, progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR.
After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine + bevacizumab + oxaliplatin bevacizumab Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR. After completion of study treatment, patients are followed every 3-6 months for up to 5 years. gemcitabine + bevacizumab + oxaliplatin gemcitabine hydrochloride Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR. After completion of study treatment, patients are followed every 3-6 months for up to 5 years. gemcitabine + bevacizumab + oxaliplatin oxaliplatin Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR. After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
- Primary Outcome Measures
Name Time Method Survival at 6 months at 6 months
- Secondary Outcome Measures
Name Time Method Objective response rate as measured by RECIST criteria Up to 5 years Median survival Up to 5 years Progression-free survival Up to 5 years Time to treatment failure Up to 5 years Overall survival Up to 5 years
Trial Locations
- Locations (196)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Scroll for more (186 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States