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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.