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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Patients receive sorafenib tosylate 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.

Interventions: intervention 1: Erlotinib Hydrochloride intervention 2: Sorafenib Tosylate
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol document: