Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer

Sponsor
Massachusetts General Hospital
Study ID
NCT00307723
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — 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.
  • 5-Fluorouracil — DRUG
    Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
  • Oxaliplatin — DRUG
    Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
  • gemcitabine — DRUG
    Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
  • External Beam Radiation Therapy — PROCEDURE
    Monday through Friday ending on day 38 of cycle 1

Study Details

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).

Key Dates

First listed
Mar 28, 2006
Start date
May 31, 2006
Status verified
Aug 2009
Primary completion
Aug 31, 2007
Completion
Jul 31, 2009

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen Level 1
    Radiation/Oxaliplatin/5-FU
  • Experimental: Regimen Level 2
    Radiation/Oxaliplatin/Bevacizumab/5-FU

Primary Outcome Measure

To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer [ Time Frame: 2 years ]

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