Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer
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.
Anaplastic Thyroid Cancer
Recurrent Thyroid Cancer
Drug: sorafenib tosylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid|
- Number of Patients With Response to Treatment Measured by RECIST Criteria [ Time Frame: at 6 months after treatment ] [ Designated as safety issue: No ]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.
- Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression. [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death. [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- To Further Characterize the Safety Profile of BAY 43-9006 When Given to Patients With Advanced Anaplastic Carcinoma of the Thyroid. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.
|Study Start Date:||June 2005|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
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.
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Panayiotis Savvides||Case Western Reserve University|