Unresectable Extrahepatic Bile Duct Cancer Clinical Trial
Official title:
Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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