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 range18 Years
SexALL
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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…
What they're measuring
1
Objective Response (Complete and Partial Response)
Timeframe: Baseline to 63 days or until disease progression