Malignant Neoplasm Clinical Trial
Official title:
A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)
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
PRIMARY OBJECTIVE:
I. Determine the objective response rate and duration of objective response in patients with
HER2/neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab
(Herceptin).
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of this drug in these patients. II. Assess the
progression-free survival and overall survival of patients treated with this drug.
OUTLINE:
Patients receive trastuzumab intravenously over 30-90 minutes on day 1. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
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