Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV
Overview
- Phase
- Phase 2
- Intervention
- imatinib mesylate
- Conditions
- Recurrent Colon Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed stage IV colorectal cancer
- •Arg, KIT (CD117), or PDGF-R expression (1+ in 20% of cells) in the tumor or microvasculature
- •At least one unidimensionally measurable lesion
- •At least 10 mm by spiral CT scan
- •No known brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •At least 12 weeks
- •Granulocyte count at least 1,500/mm\^3
- •Platelet count at least 100,000/mm\^3
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (imatinib mesylate)
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.
Intervention: imatinib mesylate
Treatment (imatinib mesylate)
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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response rate
Time Frame: Up to 4 years