Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile D… (NCT00478140) | Clinical Trial Compass
TerminatedPhase 2
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
Stopped: Due to slow accrual
United States4 participantsStarted 2007-05
Plain-language summary
This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
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.
Criteria:
* Adenocarcinoma of the gallbladder
* Recurrent extrahepatic bile duct cancer
* Recurrent gallbladder cancer
* Unresectable extrahepatic bile duct cancer
* Adenocarcinoma of the extrahepatic bile duct
* Unresectable gallbladder cancer
* Prior surgery and radiotherapy allowed
* At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered
* No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal therapy
* Concurrent hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
* No concurrent corticosteroids or anticonvulsants
* Concurrent steroids administered for antiemesis, adrenal failure, or septic shock allowed
* No concurrent combination antiretroviral therapy for HIV-positive patients
* Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct, meeting all of the following criteria: locally advanced or metastatic disease that is unresectable
* Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques or \>= 10 mm by spiral computed tomography (CT) scan
* Tumor that recurs within a previously irradiated field is considered measurable disease if recurrence is documented and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Tumor must be Her2/neu positive by Fluorescence in situ hybridization (FISH)testing
* No symptomatic brain metastases
* The Eastern Coop…
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.
What they're measuring
1
Objective Response (Complete and Partial Response)
Timeframe: Baseline to 63 days or until disease progression