BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists
• •Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization
• •Clinically or radiologically evaluable disease
• •No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
• •* At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids
• •Performance status - ECOG 0-2
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Bilirubin no greater than 1.8 mg/dL
• •ALT and AST no greater than 1.5 times upper limit of normal (ULN)
• •Creatinine no greater than 1.5 times ULN
• •No uncontrolled or significant cardiovascular disease
• •No myocardial infarction within the past 6 months
• •No prior clinically significant atrial or ventricular arrhythmias
• •No prior second or third degree heart block
• •No ischemic heart disease requiring medication
• •No congestive heart failure
• •Corrected QT interval no greater than 450 milliseconds by electrocardiogram
• •Ejection fraction at least lower limit of normal by MUGA scan
• •No uncontrolled or significant pulmonary disease
• •No active unresolved infection
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after study
• •At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• •No anthracyclines for at least 22 weeks after completion of study therapy
• •No other concurrent chemotherapy
• •Concurrent hormone replacement therapy allowed
• •No other concurrent hormonal therapy
• •At least 4 weeks since prior radiotherapy and recovered
• •No prior radiotherapy to more than 25% of the bone marrow-containing skeleton
• •No concurrent radiotherapy
• •At least 4 weeks since prior investigational agents and recovered
• •At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4)
• •At least 7 days since prior parenteral antibiotics
• •No concurrent substrates of CYP3A4
• •No concurrent parenteral antibiotics
• •No other concurrent experimental medications