Clinical Trial: S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma

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

Official Title: Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma

Brief Summary: This phase II trial is studying how well sorafenib works in treating patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma. 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

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the objective response probability (complete responses and partial responses) for BAY 43-9006 in patients with unresectable or metastatic gallbladder or cholangiocarcinoma.

II. To assess overall survival, time to treatment failure and progression-free survival in these patients.

III. To assess quantitative and qualitative toxicities of this regimen. IV. To evaluate in a preliminary fashion relevant prognostic and predictive molecular markers of clinical outcome in gallbladder and cholangiocarcinoma.

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 every 6 months for 3 years.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response probability (confirmed complete and confirmed partial responses) [ Time Frame: Up to 3 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years ]
  • Time to treatment failure [ Time Frame: From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment, assessed up to 3 years ]
  • Time to progression [ Time Frame: From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration, assessed up to 3 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 12, 2005
Date Started: October 2005
Date Completion:
Last Updated: January 11, 2013
Last Verified: January 2013