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Brief Title: Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer
Official Title: A Phase II Study of CPT-11 in Patients With Advanced Gallbladder or Bile Duct Tumors
Study ID: NCT00003276
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
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CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Siouxland Hematology-Oncology, Sioux City, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CentraCare Clinic, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Quain & Ramstad Clinic, P.C., Bismarck, North Dakota, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Altru Health Systems, Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Saskatchewan Cancer Agency, Regina, Saskatchewan, Canada
Name: Steven R. Alberts, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR