Clinical Trial: S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer

Brief Summary: 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

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Response [ Time Frame: Up to 3 years ]
  • Progression-free survival [ Time Frame: From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 3 years ]
    A 95% confidence interval will be provided.
  • Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years ]
    A 95% confidence interval will be provided.
  • Toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 3 years ]
    A 95% confidence interval will be provided.
  • Effects of the agent on the Ras signal transduction pathway [ Time Frame: Up to 3 years ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 9, 2004
Date Started: October 2004
Date Completion:
Last Updated: February 27, 2013
Last Verified: February 2013