| Exclusion Criteria: | 1) Chemotherapy or palliative radiotherapy for recurrent and/or metastatic disease within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier. Concomitant chemoradiation therapy within 6 weeks prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier.
2) Other anti-neoplastic agents, i.e., cytotoxic chemotherapy, immunotherapy, radiotherapy or investigational therapy, used to treat the primary disease will not be allowed during the study. Local radiation (excluding radiotherapy to the target lesion) for supportive reasons involving a small radiation field may be allowed.
3) Patient has a history of uncontrolled or severe medical disease which could compromise participation in the study such as uncontrolled diabetes (fasting blood glucose >200 mg/dl), uncontrolled hypertension (systolic BP>160 or diastolic BP>100 mm Hg), severe infection (bacterial infection requiring antibiotics or HIV), angina at rest, congestive heart failure NYHA class III or IV, ventricular arrhythmias requiring therapy, myocardial infarction within 6 months, (stated below), >grade 2 neuropathy.
4) Patients may not be receiving any other investigational agents.
5) Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4 are ineligible.
6) Echocardiogram less than institutional normal measured by echocardiogram for subjects with history of congestive heart failure, symptoms of congestive heart failure, clinical evidence suggesting impaired cardiac function.
7) Patients may not have any clinically significant cardiovascular disease including the following: myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc>480 msec (Fridericia correction), major conduction abnormality (unless a cardiac pacemaker is present).
8) Pregnant women & women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test w/in 24 hours prior to enrolling in the study. All sexually active females of child-bearing potential & all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, IUD) or sexual abstinence while in the study & for two months following completion of therapy. Postmenopausal women must be amenorrheic for at least 12 mths to be considered of non-childbearing potential.
9) Patients having pleural effusion |