A Phase II Study of High Dose Cetuximab Plus Irinotecan in Colorectal Cancer Patients With KRS-Wild Type Tumors Who Progressed After Failure of Prior Standard Dose ofCetuximab Plus Irinotecan
Cetuximab is a manufactured antibody-antibodies are proteins that can be found circulating
in your blood stream. The growth of colorectal cancer may be affected by the interaction of
a growth factor known as "epidermal growth factor" (EGF) with its receptor.
Cetuximab is a antibody directed against the receptor for EGF and has been shown to turn off
the activity of the receptor and to stop the growth of cancer cells in many laboratory
tests. Cetuximab has been recently approved by the Food and Drug Administration in the
treatment of patients with advanced colorectal cancer and who failed standard chemotherapy.
Cetuximab has been shown to delay the progression of colorectal cancer when given alone in
patients who have failed standard chemotherapy and when given with a chemotherapy drug
called irinotecan in patients who have failed irinotecan.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the rate of 12-week progression free survival rate upon escalation of cetuximab dose to 500mg/m2 in combination with irinotecan after progression on standard dose therapy in patients with KRS wild type colorectal cancer
WenWee Ma, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|