Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or Stomach

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00004235
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 combining docetaxel and irinotecan in treating patients who have advanced cancer of the esophagus or stomach.

Key Dates

Start date
Jan 31, 2000
Status verified
Jul 2016
Primary completion
Aug 31, 2004
Completion
Aug 31, 2004

Study Design

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

Arms

  • Experimental: irinotecan + docetaxel
    Patients receive irinotecan IV over 90 minutes followed by docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response (CR) receive 2 additional courses after CR. Patients experiencing disease progression after a CR and 2 additional courses may be retreated with irinotecan and docetaxel. Dysphagia, anorexia, and swallowing ability are assessed before the first course of treatment and then at each tumor assessment. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Primary Outcome Measure

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

Locations (18)

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 - Missouri Valley Cancer ConsortiumOmahaNebraska68131-
Medcenter One Health SystemBismarckNorth Dakota58501-
CCOP - Merit Care HospitalFargoNorth Dakota58122-
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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