Clinical trial NCT00956072 (phase 3, status: terminated)
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
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastrointestinal stromal tumor expressing CD117+ or with
             documented mutation of the KIT or PDGFRA gene

          -  Metastatic disease (liver and/or abdominal cavity)

               -  No extra-abdominal metastases

          -  Measurable disease according to RECIST criteria

          -  Achieved complete response, partial response, or stable disease without progression
             since the start of imatinib mesylate therapy, documented according to RECIST

          -  Underwent 6-12 months of treatment with imatinib mesylate as a standard of care or
             within other clinical studies (surgery should be feasible before the end of the 12th
             month from imatinib mesylate onset)

          -  Surgically resectable residual disease as assessed by CT scan and/or MRI within the
             past 14 days

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-1

          -  ANC > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Creatinine < 120 μmol/L

          -  Albumin > 25 g/L

          -  Total bilirubin < 2 times upper limit of normal (ULN)

          -  AST and ALT < 2.5 times ULN (< 5 ULN in case of liver metastases)

          -  Alkaline phosphatase < 2.5 times ULN (< 5 ULN in case of bone or liver metastases)

          -  Negative pregnancy test within the past 14 days

          -  Fertile patients must use effective contraception

          -  No uncontrolled hypertension (diastolic BP > 95 mm Hg and systolic BP > 170 mm Hg)

          -  No myocardial infarction, unstable, or uncontrolled cardiac disease within the past 6
             months

          -  No history of arterial thrombosis or deep vein thrombosis within the past year

          -  No bleeding diathesis, coagulopathy, or major bleeding within the past 6 months

          -  No severe and/or uncontrolled concurrent medical disease, including any of the
             following conditions:

               -  Diabetes

               -  Chronic renal disease

               -  Liver disease, including chronic viral hepatitis judged at risk of reactivation

               -  Active infection, including HIV infection

          -  No prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal
             cell or squamous cell cancer of the skin) unless treated with curative intent and
             without evidence of disease for at least 3 years

          -  No psychological, familial, sociological, or geographical condition potentially
             hampering compliance with the study protocol and follow-up schedule

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior adjuvant or neo-adjuvant imatinib mesylate or other tyrosine kinase inhibitor

          -  No coumadin-type anticoagulant > 2mg/day within the past 7 days

          -  No major surgery within the past 28 days

          -  No medication that interacts moderately or strongly with the CYP3A system within the
             past 14 days