NCT00041340

Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer. Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth

Detailed description

PRIMARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-05-01
• Primary completion: 2006-07-01
• First posted: 2003-01-27
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States