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Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression (NCT00003995)

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.
  • Biological: trastuzumab
    • Drug: irinotecan hydrochloride
      Ages eligible for Study
      Genders eligible for Study
      Accepts Healthy Volunteers

      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.

      5 locations

      United States (5)
      • Albert Einstein Comprehensive Cancer Center
        Not specified
        Bronx, New York, United States, 10461
      • University of Pittsburgh Cancer Institute
        Not specified
        Pittsburgh, Pennsylvania, United States, 15213
      • Lifespan: The Miriam Hospital
        Not specified
        Providence, Rhode Island, United States, 02906
      • Sarah Cannon-Minnie Pearl Cancer Center
        Not specified
        Nashville, Tennessee, United States, 37203
      • University of Texas - MD Anderson Cancer Center
        Not specified
        Houston, Texas, United States, 77030
      31 August, 1999
      06 February, 2013
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