NCT00003276

Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Gallbladder Cancer

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1998-03-01
• Primary completion: 2001-03-01
• Completion: 2001-03-01
• First posted: 2004-04-30
• Last updated: 2016-07-06

Locations

21 sites across 2 countries: United States, Canada