Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2

Part of paid clinical trials in The Bronx, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00003995
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Key Dates

Start date
Sep 30, 1999
Status verified
Jun 2007
Primary completion
Mar 31, 2006

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive a loading dose of trastuzumab IV over 90 minutes on week 1, and over 30-90 minutes weekly thereafter. Patients receive irinotecan IV over 90 minutes following trastuzumab weekly for 4 weeks. Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.

Locations (5)

FacilityCityStateZIPSite coordinators
Albert Einstein Comprehensive Cancer CenterThe BronxNew York10461-
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15213-
Lifespan: The Miriam HospitalProvidenceRhode Island02906-
Sarah Cannon-Minnie Pearl Cancer CenterNashvilleTennessee37203-
University of Texas - MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in The Bronx, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Albert Einstein Comprehensive Cancer Center· The Bronx, NYUniversity of Pittsburgh Cancer Institute· Pittsburgh, PALifespan: The Miriam Hospital· Providence, RISarah Cannon-Minnie Pearl Cancer Center· Nashville, TNUniversity of Texas - MD Anderson Cancer Center· Houston, TX

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