Tongue Cancer Clinical Trial
Official title:
Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cance
PRIMARY OBJECTIVES:
I. To evaluate the response probability (confirmed, complete and partial responses) in
patients with metastatic head and neck cancer who are treated with BAY 43-9006.
II. To evaluate median progression-free survival and median overall survival. III. To
evaluate the qualitative and quantitative toxicities of this regimen. IV. To investigate in
a preliminary manner the effects of the agent on the Ras signal transduction pathway in
tissue samples obtained prior to and after treatment.
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.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3.3-8
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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