GW786034 in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed advanced solid tumor
• •Refractory to standard therapy or for which no standard therapy exists
• •No untreated leptomeningeal or brain metastases
• •* Previously treated brain metastases are allowed if currently asymptomatic and patient is off steroids and antiseizure medications for more than 3 months before study entry
• •PATIENT CHARACTERISTICS:
• •Age
• •21 and over
• •Performance status
• •Karnofsky 70-100%
• •Life expectancy
• •At least 12 weeks
• •Hematopoietic
• •Absolute granulocyte count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hemoglobin at least 9 g/dL
• •Hepatic
• •Bilirubin no greater than 1.5 mg/dL
• •AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if tumor involvement)
• •Renal
• •Creatinine clearance at least 60 mL/min
• •Cardiovascular
• •No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg on 2 consecutive measurements separated by 1 week)
• •No arterial or venous thrombosis (including cerebrovascular accident) within the past 3 months
• •No myocardial infarction within the past 3 months
• •No unstable angina within the past 3 months
• •No cardiac angiopathy or stenting within the past 3 months
• •No cardiac pacemaker
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 21 days after study treatment
• •Able to swallow and retain oral medication
• •Good venous access
• •No prior or concurrent gastrointestinal disease
• •No prior or concurrent condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
• •No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug
• •No other unstable, pre-existing major medical condition
• •No orthopedic pins or rods or other embedded metal that would preclude undergoing an MRI
• •No psychological, familial, sociological, or geographical condition that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •More than 4 weeks since prior immunotherapy
• •Concurrent epoetin alfa allowed
• •No concurrent anticancer biologic therapy
• •Chemotherapy
• •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• •No concurrent anticancer cytotoxic chemotherapy
• •Endocrine therapy
• •See Disease Characteristics
• •More than 4 weeks since prior hormonal or steroid therapy (other than replacement)
• •No concurrent anticancer hormonal therapy (except for replacement)
• •No concurrent dexamethasone or prednisone
• •Radiotherapy
• •More than 4 weeks since prior radiotherapy
• •No concurrent anticancer radiotherapy
• •Surgery
• •More than 4 weeks since prior major surgery
• •No concurrent surgery for cancer
• •Other
• •Recovered from prior therapy
• •More than 4 weeks since prior investigational agents
• •More then 28 days since prior alteration of antihypertensive medications
• •Concurrent bisphosphonates allowed
• •No other concurrent anticancer therapy
• •No concurrent antidepressants (e.g., amitriptyline, fluoxetine, or fluvoxamine)
• •No concurrent oral hypoglycemics (e.g., glipizide, glyburide, rosiglitazone, or tolbutamide)
• •No concurrent therapeutic anticoagulation (e.g., warfarin at therapeutic doses)
• •* Low-dose anticoagulation for prophylaxis allowed
• •No concurrent cyclosporine
• •No concurrent grapefruit juice
• •No concurrent amiodarone, mibefradil, phenobarbital, or pioglitazone
• •No concurrent Hypericum perforatum (St. John's Wort)
• •No concurrent rifabutin or diethyldithiocarbamate
• •No concurrent gestodene, mifepristone, or modafinil
• •No concurrent herbal supplements, vitamins, or non-traditional compounds