Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00003351
Phase
PHASE2
Status
Completed

Conditions

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: Randomized phase II trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer.

Key Dates

Start date
Aug 31, 1998
Status verified
Jul 2016
Primary completion
Oct 31, 2006
Completion
Oct 31, 2006

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: irinotecan
    Patients receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year.
  • Experimental: Arm II: irinotecan
    Patients receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks. Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before and during treatment. Patients are followed every 3 months for 2 years, then annually for 1 year.

Primary Outcome Measure

Time to progression [ Time Frame: Up to 3 years ]

Locations (21)

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-
CCOP - DuluthDuluthMinnesota55805-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CentraCare ClinicSaint CloudMinnesota56303-
CCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68131-
Medcenter One Health SystemBismarckNorth 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-

Find similar trials in Scottsdale, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
CCOP - Scottsdale Oncology Program· Scottsdale, AZCCOP - Illinois Oncology Research Association· Peoria, ILCCOP - Carle Cancer Center· Urbana, ILCCOP - Cedar Rapids Oncology Project· Cedar Rapids, IACCOP - Iowa Oncology Research Association· Des Moines, IASiouxland Hematology-Oncology· Sioux City, IA

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