Irinotecan in Treating Patients With Advanced Gallbladder or Bile Duct Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00003276
Phase
PHASE2
Status
Completed

Conditions

  • Gallbladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 1998
Status verified
Jul 2016
Primary completion
Mar 31, 2001
Completion
Mar 31, 2001

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan
    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.

Primary Outcome Measure

objective tumor response rate [ Time Frame: Up to 5 years ]

Locations (20)

FacilityCityStateZIPSite coordinators
CCOP - Scottsdale Oncology ProgramScottsdaleArizona85259-5404-
CCOP - Illinois Oncology Research AssociationPeoriaIllinois61602-
CCOP - Carle Cancer CenterUrbanaIllinois61801-
CCOP - Cedar Rapids Oncology ProjectCedar RapidsIowa52403-1206-
CCOP - Iowa Oncology Research AssociationDes MoinesIowa50309-1016-
Siouxland Hematology-OncologySioux CityIowa51101-1733-
CCOP - WichitaWichitaKansas67214-3882-
CCOP - OchsnerNew OrleansLouisiana70121-
CCOP - Ann Arbor RegionalAnn ArborMichigan48106-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CentraCare ClinicSaint CloudMinnesota56303-
CCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68131-
Quain & Ramstad Clinic, P.C.BismarckNorth Dakota58501-
CCOP - Merit Care HospitalFargoNorth Dakota58122-
Altru Health SystemsGrand ForksNorth Dakota58201-
CCOP - Toledo Community Hospital Oncology ProgramToledoOhio43623-3456-
CCOP - Geisinger Clinic and Medical CenterDanvillePennsylvania17822-2001-
Rapid City Regional HospitalRapid CitySouth Dakota57709-
CCOP - Sioux Community Cancer ConsortiumSioux FallsSouth Dakota57105-1080-

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