Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
I. To determine response to Gleevec (Imatinib Mesylate) in patients with metastatic
colorectal cancer and with c-Kit, Arg, Abl, or PDGF-R expression.
II. To determine the side effects of Imatinib Mesylate in patients with colorectal cancer.
III. To study the biologic effects of Imatinib Mesylate on the c-Kit and PDGF-R system and
downstream signaling in metastatic colorectal cancer.
Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the
absence of disease progression or unacceptable toxicity. Patients with stable disease or
better continue therapy until disease progression or 1 year after complete response.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Up to 4 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|