Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unrese… (NCT01093222) | Clinical Trial Compass
CompletedPhase 2
Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma
United States40 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma
* No ampullary carcinoma
* Locally advanced unresectable or distant metastatic disease
* Measurable disease
* Patients with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage
* No prior systemic treatment for metastatic or unresectable locally advanced disease
* No known brain metastases
* Zubrod performance status of 0-1
* Leukocyte count ≥ 3,000/mm\^3
* ANC ≥ 1,000/mm\^3
* Platelet count ≥100,000/mm\^3
* Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* For patient who had decompression of the biliary tree within the past 14 days, stability of the bilirubin level needs to be confirmed with two measurements within 5 to 7 days of each other
* Serum albumin ≥ 2.5 g/dL
* AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
* Creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Fertile patients must agree to use effective contraception
* No active biliary sepsis
* No bleeding diathesis
* No uncontrolled or clinically significant cardiovascular disease, including any of the following:
* Myocardial infarction within the past 6 months
* Uncontrolled angina within the past 6 months
* NYHA class II-IV congestive heart failure
* Grade 3 cardiac valve dysfunction
* Cardiac arrhythmia not controlled by medication
* History of stroke or transient ischemic attack within t…