Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Recruitment status was Recruiting
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.
Drug: gemcitabine hydrochloride
Drug: sorafenib tosylate
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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.|
- Progression-free survival [ Designated as safety issue: No ]
- Toxicities [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Clinical benefits [ Designated as safety issue: No ]
- Quality of life by QLQ-C30 [ Designated as safety issue: No ]
- Biomarkers of response [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541021
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes||Recruiting|
|Marseille, France, 13273|
|Contact: Frederic Viret, MD 33-4-91-22-35-37 firstname.lastname@example.org|
|Investigator:||Frederic Viret, MD||Institut Paoli-Calmettes|