Clinical trial NCT00573404 (phase 1, 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, sunitinib malate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1, CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Biopsy proven gastrointestinal stromal tumor

          -  Patients previously treated with imatinib mesylate must have documented progression of
             disease

               -  Untreated disease allowed

          -  Must have ≥ 1 measurable lesion by RECIST

          -  No history of or known brain metastases, spinal cord compression,carcinomatous
             meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT
             or MRI scan

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,500/μL

          -  Hemoglobin ≥ 9.0 g/dL

          -  Platelet count ≥ 150,000/μL

          -  Total serum bilirubin ≤ 2.0 mg/dL

          -  Serum calcium ≤ 12.0 mg/dL

          -  Serum creatinine ≤ 1.8 mg/dL

          -  AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver function
             abnormalities are due to underlying malignancy)

          -  Able to take oral medications

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No grade 3 hemorrhage within the past 4 weeks

          -  No myocardial infarction, severe or unstable angina, coronary or peripheral artery
             bypass graft, symptomatic congestive heart failure, cerebrovascular accident or
             transient ischemic attack, or pulmonary embolism within the past 6 months

          -  No ongoing cardiac dysrhythmias ≥ grade 2

          -  No prolonged QTc interval on baseline EKG

          -  No hypertension that cannot be controlled by medications (BP > 150/100 mm Hg, despite
             medical therapy)

          -  No pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication

          -  No known HIV or AIDS-related illness or other active infection

          -  No other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator, preclude study entry

          -  No malabsorption syndrome

          -  No prior intolerance of imatinib mesylate or toxicity necessitating dose modification

          -  No prior intolerance of sunitinib malate or toxicity necessitating dose modification

        PRIOR CONCURRENT THERAPY:

          -  Recovered from all acute toxic effects of prior chemotherapy, radiotherapy, or
             surgical procedures

          -  No major surgery or radiotherapy within the past 4 weeks

          -  No concurrent treatment on another clinical trial, except supportive care trials or
             non-treatment trials (e.g., quality of life)

          -  No concurrent ketoconazole and other agents known to induce CYP3A4

          -  No concurrent theophylline or phenobarbital and/or other agents metabolized by the
             cytochrome P450 system

          -  No ongoing therapeutic doses of coumadin, except low-dose oral coumadin up to 2 mg
             once daily for thrombosis prophylaxis

          -  No concurrent Hypericum perforatum (St. John's wort) or other herbal medications