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Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

NCT01093222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-06-30

Study results available
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Summary

This phase II trial is studying how well giving sorafenib tosylate together with erlotinib hydrochloride works in treating patients with locally advanced, unresectable, or metastatic gallbladder cancer or cholangiocarcinoma. Sorafenib tosylate and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Conditions

  • Extrahepatic Bile Duct Adenocarcinoma
  • Gallbladder Adenocarcinoma
  • Gallbladder Adenocarcinoma With Squamous Metaplasia
  • Hilar Cholangiocarcinoma
  • Recurrent Extrahepatic Bile Duct Carcinoma
  • Recurrent Gallbladder Carcinoma
  • Undifferentiated Gallbladder Carcinoma
  • Unresectable Extrahepatic Bile Duct Carcinoma
  • Unresectable Gallbladder Carcinoma

Interventions

DRUG

Erlotinib Hydrochloride

Given PO

DRUG

Sorafenib Tosylate

Given PO

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

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-09-30
Completion
2014-09-30

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 NCT01093222 on ClinicalTrials.gov