Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.
- Compare progression-free survival.
- Compare toxicities.
- Compare response rate.
- Compare overall survival.
- Evaluate clinical benefits.
- Compare quality of life.
- Identify biomarkers that predict therapeutic response.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate twice daily and gemcitabine
hydrochloride IV once weekly for 7 weeks followed by 1 week of rest (course1). For the
next 2 courses, patients receive gemcitabine hydrochloride weekly for 3 weeks followed
by 1 week of rest and sorafenib tosylate twice daily.
- Arm II: Patients receive oral placebo twice daily and gemcitabine hydrochloride as in
After completing 3 courses of therapy, patients in both arms who have stable or responding
disease may continue to receive sorafenib tosylate or placebo in the absence of disease
progression or unacceptable toxicity.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Frederic Viret, MD