OBJECTIVES:
Primary
* Compare progression-free survival.
Secondary
* 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 arm I.
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.
