12
Participants
Start Date
January 31, 2008
Primary Completion Date
April 30, 2011
Study Completion Date
April 30, 2011
Sorafenib Escalated Dose
Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.
Sorafenib Standard Dose
Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.
The Lancaster Cancer Center, Ltd, Lancaster
Gaston Hematology and Oncology, Gastonia
Northwest Georgia Oncology Centers, Marietta
Peachtree Hematology Oncology Consultants, Atlanta
Northeast Georgia Cancer Care, Athens
Central Georgia Cancer Care, Macon
Advanced Medical Specialties, Miami
The West Clinic, Memphis
Hematology Oncology Centers of the Northern Rockies, Billings
Mid-Illinois Hematology and Oncology Associates, Ltd., Normal
Clopton Clinic, Jonesboro
Wilshire Oncology Medical Group, Inc., La Verne
Pacific Oncology, PC, Beaverton
Collaborators (1)
Bayer
INDUSTRY
Accelerated Community Oncology Research Network
OTHER