NCT00541021

Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	sorafenib tosylate

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-12-01
• First posted: 2007-10-08
• Last updated: 2009-12-15

Locations

1 site across 1 country: France