Clinical Trial: Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Alliance for Clinical Trials in Oncology
Current Primary Outcome: objective tumor response rate [ Time Frame: Up to 5 years ]
Original Primary Outcome:
Current Secondary Outcome:
- overall survival [ Time Frame: Up to 5 years ]
- time to progression [ Time Frame: Up to 5 years ]
Original Secondary Outcome:
Information By: Alliance for Clinical Trials in Oncology
Dates:
Date Received: November 1, 1999
Date Started: March 1998
Date Completion:
Last Updated: July 1, 2016
Last Verified: July 2016
