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



Status:Archived
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010

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Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma


RATIONALE: 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.

PURPOSE: 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.


OBJECTIVES:

- To assess the progression-free survival of patients with unresectable or metastatic
gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib
tosylate and erlotinib hydrochloride.

- To assess the overall survival of patients treated with this regimen.

- To assess the objective response rate in patients treated with this regimen.

- To assess the frequency and severity of toxicities of this regimen in these patients.

- To collect specimens for banking for future research.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib tosylate twice daily and oral erlotinib hydrochloride once
daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed up every 6 months for 3 years.


We found this trial at
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171 Ashley Avenue
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Flint, Michigan 48503
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Gainesville, Florida 32611
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2700 Wayne Memorial Drive
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701 Ilalo Street Suite 600
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1415 E. Kincaid
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19500 10th Ave NE # 100
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2279 45th Street
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