Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
NCT00307723 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2009-08-10
Summary
The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer (Phase II portion).
Conditions
Interventions
- DRUG
-
Intravenously on days 1, 15 and 29 of the first cycle. Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
- DRUG
-
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
- DRUG
-
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
- DRUG
-
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
- PROCEDURE
-
External Beam Radiation Therapy
Monday through Friday ending on day 38 of cycle 1
Sponsors & Collaborators
- collaborator OTHER
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Genentech, Inc.
collaborator INDUSTRY - collaborator INDUSTRY
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Lawrence S. Blaszkowsky, MD · Massachusetts General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-05-31
- Primary Completion
- 2007-08-31
- Completion
- 2009-07-31
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