This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. 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.
OBJECTIVES: I. Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib. II. Determine the survival of patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the pharmacokinetic predictors of response to this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given orally
Case Western Reserve University
Cleveland, Ohio, United States
Number of Patients With Response to Treatment Measured by RECIST Criteria
Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, x-ray) or as \>10 mm with spiral CT scan.
Time frame: at 6 months after treatment
Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.
Time frame: 27 months
Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.
Time frame: 27 months
Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006
The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.
Time frame: 27 months
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