Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced
or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II.
Determine the tolerablility and clinical benefit of this regimen in these patients. III.
Evaluate the progression free survival and the overall survival of these patients when
treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5
hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the
absence of disease progression or unacceptable toxicity. Patients with locally advanced
disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Primary Purpose: Treatment
Christophe Louvet, MD, PhD
Hopital Saint Antoine
United States: Federal Government