Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

Intervention / Treatment
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* Drug: imatinib mesylate
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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 Bilirubin no greater than 2.0 mg/dL AST/ALT less than 2.5 times upper limit of normal Creatinine no greater than 2.0 mg/mL No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix No concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered More than 4 weeks since prior radiotherapy and recovered More than 3 weeks since prior surgery (excluding diagnostic biopsy) No other concurrent investigational agents No concurrent therapeutic doses of anticoagulants (e.g., warfarin) No concurrent grapefruit No concurrent combination antiretroviral therapy for HIV-positive patients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (imatinib mesylate)<br>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. | Drug: imatinib mesylate<br>* Given orally<br>* Other names: Glivec;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Up to 4 years |