| Exclusion Criteria: | 1) Have received previous anticancer chemotherapy, immunotherapy, radiotherapy, or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry.
2) Have received extensive prior radiotherapy on more than 30% of bone marrow reserves or prior bone marrow/stem cell transplantation.
3) Have any concomitant condition that could compromise the objectives of this study the patient's compliance, including but not limited to, the following: congestive heart failure or angina pectoris even if medically controlled, previous history of myocardial infarction within 6 months from study entry, uncontrolled hypertension, or arrhythmias; active infection; unstable diabetes mellitus; medically significant interstitial pneumonitis; or psychiatric disorder that may interfere with consent and/or protocol compliance.
4) Pregnant or lactating women.
5) Have current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, or have demonstrated no evidence of disease for 5 years or more.
6) Have clinically evident HIV, HBV, or HCV infection.
7) Have a hematologic malignancy.
8) Have a documented or known bleeding disorder.
9) Require anticoagulation treatment that increases INR or a PTT above the normal range (low dose deep vein thrombosis [DVT] or line prophylaxis is allowed).
10) Have clinically evident: brain disorder, leptomeningeal disease, or seizure disorder (baseline CT or MRI scan of brain is required only in the case of clinical suspicion of central nervous system metastases). |