Clinical trial NCT00041197 (phase 3, status: completed)
Conditions: gastrointestinal stromal tumor
ICD codes: C49.A0, C49.A1, C49.A2, C49.A5, C49.A3, C49.A4, C49.A9
Drugs: imatinib mesylate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have an ECOG/Zubrod performance status of =< 2

          -  Patient must have a histologic diagnosis of primary GIST (without peritoneal or
             distant metastasis) that expresses Kit protein by immunohistochemistry and have tumor
             size >= 3cm in maximum dimension

          -  Patient must have undergone complete gross resection (includes R0 [negative
             microscopic margins] and R1 [positive microscopic margins]) of a primary GIST within
             70 days prior to registration

          -  Patient must have a chest x-ray completed within 28 days prior to registration; NOTE:
             Chest CT within 28 days prior to registration can be used in lieu of chest x-ray

          -  Patient must have a post-operative CT scan with IV and PO contrast or MRI with
             contrast (if allergic to CT contrast) of abdomen and pelvis within 28 days prior to
             registration

          -  Creatinine =< 1.5 times the institution ULN

          -  WBC >= 2,000/mm^3

          -  Platelets >= 100,000/mm^3

          -  Total Bilirubin =< 1.5 times the institution ULN; NOTE: Patients with elevated
             bilirubin secondary to Gilbert's disease are eligible to participate in the study

          -  AST =< 2.5 times the institution ULN

          -  ALT =< 2.5 times the institution ULN

          -  Female of childbearing potential must have negative serum pregnancy test; NOTE:
             Post-menopausal women must be amenorrheic for at least 12 months to be deemed not of
             reproductive potential

          -  Patient or the patient's legally acceptable representative must provide a signed and
             dated written informed consent prior to registration and any study-related procedures

          -  Patient must provide written authorization to allow the use and disclosure of their
             protected health information; NOTE: This may be obtained in either the study-specific
             informed consent or in a separate authorization form and must be obtained from the
             patient prior to study registration (non-US sites are exempt from HIPAA regulations)

          -  If patient is a cancer survivor, ALL of the following criteria apply:

               -  Patient has undergone potentially curative therapy for all prior malignancies

               -  No evidence of any prior malignancies for at least 5 years with no evidence of
                  recurrence (except for effectively treated basal cell or squamous carcinoma of
                  the skin, carcinoma in-situ of the cervix that has been effectively treated by
                  surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral
                  breast treated by surgery alone)

               -  Patient is deemed by their treating physician to be at low risk for recurrence
                  from prior malignancies

        Exclusion Criteria:

          -  Patient has received post-operative chemotherapy

          -  Patient has received post-operative radiation therapy

          -  Patient has received post-operative investigational treatment

          -  Patient has received prior therapy with STI571

          -  Patient has had an active infection requiring antibiotics within 14 days prior to
             registration

          -  Patient has objective evidence of residual disease on the postoperative CT scan or MRI
             of the abdomen or pelvis

          -  Patient, if female and breastfeeding; NOTE: It is not known whether STI571or its
             metabolites are excreted in human milk; however, in lactating female rats administered
             100mg/kg, a dose approximately equal to the maximum clinical dose of 800mg/day based
             on body surface area, STI571 and /or its metabolites were extensively excreted in
             milk; it is estimated that approximately 1.5% of a maternal dose is excreted into
             milk, which is equivalent to a dose to the infant of 30% the maternal dose per unit
             body weight; women should be advised against breastfeeding while taking STI571

          -  Patient has New York Heart Association class 3 or 4 cardiac disease

          -  Patient is taking full dose warfarin; NOTE: The use of mini-dose warfarin (1mg orally
             per day) for prevention of central line-associated deep venous thrombosis is permitted