Pancreatic Cancer Clinical Trial
Official title:
Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.
RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth and by blocking blood flow to the tumor. It is not yet known whether giving
gemcitabine together with sorafenib is more effective than giving gemcitabine alone in
treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with
sorafenib to see how well it works compared with giving gemcitabine alone in treating
patients with locally advanced or metastatic pancreatic cancer.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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