Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

Inclusion criteria:

At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
Must have received previous chemotherapy
Must be 18 years of age of greater
Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
At least 2 weeks must have elapsed since any surgery
At least 4 weeks must have elapsed since any radiation to a non-CNS site
Must have adequate bone marrow, renal, and live capacities
Women must be of non-childbearing potential or practice adequate birth control
Males must practice adequate methods of birth control
Must sign written informed consent

Exclusion criteria:

Previous whole brain radiation therapy
Prior treatment with topotecan
Investigational agent within 30 days or 5 half-live
Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
Primary or secondary immunodeficiencies
Gastrointestinal conditions that affect GI absorption or motility
Uncontrolled emesis
Brain metastasis at time of initial diagnosis of NSCLC
History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
Pregnant or intending to become pregnant or intending to father a baby
Any severe concurrent medical condition that could affect compliance.