Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
NCT ID: NCT00041340
Last Updated: 2013-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2002-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
imatinib mesylate
Given orally
laboratory biomarker analysis
Correlative studies
Interventions
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imatinib mesylate
Given orally
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Razelle Kurzrock
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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ID01-557
Identifier Type: -
Identifier Source: secondary_id
CDR0000069475
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02479
Identifier Type: -
Identifier Source: org_study_id
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