Irinotecan in Treating Patients With Advanced Cancer of the Stomach

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00003137
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: Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced cancer of the stomach.

Key Dates

Start date
Dec 31, 1997
Status verified
Jul 2016
Primary completion
Jul 31, 2004
Completion
Jul 31, 2004

Study Design

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

Arms

  • Experimental: irinotecan
    Patients receive irinotecan (CPT-11) by IV over 90 minutes every 3 weeks. Dosage modifications are made based on toxicity. Retreatment may be delayed another 3 weeks (for a total of 6 weeks) to allow for recovery from toxic effects. Patient is taken off study if they do not recover from toxic effects, unless cause is documented to be unrelated to CPT-11. Patients with stable disease or partial response continue on treatment until disease progression or intolerable toxicity. Patients with complete response continue on treatment for another 2 courses and then are observed. Patients are followed every 3 months for 3 years or until disease progression.

Primary Outcome Measure

response rate [ Time Frame: Up to 3 years ]

Locations (18)

FacilityCityStateZIPSite coordinators
CCOP - Scottsdale Oncology ProgramScottsdaleArizona85259-5404-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
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 - DuluthDuluthMinnesota55805-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CentraCare ClinicSaint CloudMinnesota56303-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68131-
Medcenter One Health SystemBismarckNorth Dakota58501-
CCOP - Merit Care HospitalFargoNorth Dakota58122-
Altru Health SystemsGrand ForksNorth Dakota58201-
CCOP - Geisinger Clinic and Medical CenterDanvillePennsylvania17822-2001-
Rapid City Regional HospitalRapid CitySouth Dakota57709-
CCOP - Sioux Community Cancer ConsortiumSioux FallsSouth Dakota57104-

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