Gallbladder Cancer Clinical Trial
Official title:
A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with
advanced gallbladder or bile duct cancer that cannot be removed surgically.
OBJECTIVES: I. Evaluate the objective tumor response rate in patients with advanced
gallbladder or bile duct tumors treated with irinotecan. II. Evaluate time-to-progression,
survival, and toxic effects associated with irinotecan given weekly for 4 weeks every 6
weeks in this patient population.
OUTLINE: Patients receive a 90 minute continuous infusion of irinotecan on days 1, 8, 15,
and 22 for 4 weeks, followed by a 2 week rest period. Courses of treatment are repeated
every 42 days. Patients continue treatment in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months
for the next 4 years.
PROJECTED ACCRUAL: Approximately 22-40 patients will be accrued for this study over 2-4
years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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