Clinical Trials Directory

Trials / Completed

CompletedNCT00238212

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
—
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGsorafenib tosylateGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2005-10-01
Primary completion
2007-01-01
First posted
2005-10-13
Last updated
2013-01-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00238212. Inclusion in this directory is not an endorsement.