Sorafenib With or Without Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Liver Cancer
NCT00941967 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2019-07-10
Summary
RATIONALE: Sorafenib tosylate 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. Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether sorafenib tosylate is more effective when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer.
PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it works when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with locally advanced, unresectable, or metastatic liver cancer.
Conditions
Interventions
- DRUG
-
gemcitabine hydrochloride
Given IV
- DRUG
-
Given IV
- DRUG
-
sorafenib tosylate
Given orally.
Sponsors & Collaborators
-
Institut du Cancer de Montpellier - Val d'Aurelle
lead OTHER
Principal Investigators
-
Eric Assenat, MD · Hopital Saint Eloi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-12-31
- Primary Completion
- 2010-12-31
- Completion
- 2012-12-31
Countries
- France
Study Locations
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