Phase II and Pharmacokinetic Study of CPT-11 and Trastuzumab (RhuMab HER2, Herceptin) in Advanced Colo-Rectal Cancer With p185 HER 2 Overexpression
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ramesh K. Ramanathan, MD
University of Pittsburgh
United States: Food and Drug Administration
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Sarah Cannon-Minnie Pearl Cancer Center||Nashville, Tennessee 37203|
|Lifespan: The Miriam Hospital||Providence, Rhode Island 02906|