 - Known active uncontrolled or symptomatic central nervous system CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, andor progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated eg, radiotherapy, stereotactic surgery and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization . 