Hilar Cholangiocarcinoma Clinical Trial
Official title:
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients With Advanced Gallbladder Carcinoma or Cholangiocarcinoma
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.
OBJECTIVES:
I. To assess the progression-free survival in patients with unresectable or metastatic
gallbladder carcinoma or cholangiocarcinoma treated with the combination of sorafenib
(sorafenib tosylate) and erlotinib (erlotinib hydrochloride).
II. To assess the overall survival in patients with unresectable or metastatic gallbladder
carcinoma or cholangiocarcinoma treated with the combination of sorafenib and erlotinib.
III. To assess the objective response rate. IV. To assess the frequency and severity of
toxicities. V. To collect specimens for banking for future research.
OUTLINE: This is a multicenter study.
Patients receive sorafenib tosylate orally (PO) twice daily and erlotinib hydrochloride PO
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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