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.
OBJECTIVES: I. Determine the objective response rate of irinotecan and trastuzumab in patients with stage IV colorectal cancer and p185 HER2 overexpression. II. Evaluate the safety and toxic effects of this treatment regimen in these patients. III. Determine the overall survival and time to progression in these patients in response to this treatment regimen. IV. Determine the pharmacokinetics of trastuzumab in combination with irinotecan and antibodies to trastuzumab in these patients. V. Determine the expression of HER2/neu in these patients. OUTLINE: This is a multicenter study. 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. Patients are followed every 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
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