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

NCT00238212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-01-14

No results posted yet for this study

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

Conditions

  • Adenocarcinoma of the Extrahepatic Bile Duct
  • Adenocarcinoma of the Gallbladder
  • Adenocarcinoma With Squamous Metaplasia of the Gallbladder
  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Cholangiocarcinoma of the Gallbladder
  • Recurrent Extrahepatic Bile Duct Cancer
  • Recurrent Gallbladder Cancer
  • Squamous Cell Carcinoma of the Gallbladder
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer

Interventions

DRUG

sorafenib tosylate

Given orally

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Anthony El-Khoueiry · SWOG Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00238212 on ClinicalTrials.gov