A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)
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
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.
Patients receive trastuzumab IV 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (complete and partial response)
Up to 4.5 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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