Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer
About this trial
This is an interventional treatment trial for Recurrent Colon Cancer
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 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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
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.