An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma (NSCLC)
Inclusion Criteria:
- Measurable disease as defined by the presence of at least one measurable lesion
- Patients must have received at least 3 weeks of continuous therapy with Taxane -
patient must subsequently develop progressive disease either during treatment or
within 6 months after treatment
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and kidney function
Exclusion Criteria:
- Excluded medical conditions like: pre-existing neuropathy, active heart diseases or
ischemia, serious infections, HIV infection, chronic hepatitis B or C; brain
metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous
cancers
- excluded therapies and medications, previous and concomitant such as: anticancer
chemotherapy or immunotherapy during the study or within 4 weeks prior to study
entry; more than two prior anticancer chemotherapy regimens; radiotherapy during
study or within 4 weeks prior to study entry; bone marrow transplant.
- others: pregnant or breast-feeding patients; both men and women enrolled in this
trial must use adequate barrier birth control measures during the course of the
trial; substance abuse, medical, psychological or social conditions that may
interfere with the patient's participation.