Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

• Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
• IIIA: T1-3 N2 M0, T3 N1 M0
• IIIB: T4 N0-2 M0, T 1-4 N3 M0
• Measurable or evaluable disease
• Previously untreated with chemotherapy or radiotherapy for lung cancer;
• No brain metastases;
• No prior XRT
• Performance status 0-2
• ≥18 years of age
• Informed Consent
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)
• SGOT and SGPT ≤ 2.5 x ULN for the institution
• Creatinine ≤ 1.6 mg/dL
• Hemoglobin ≥ 8.0 g/dL
• Peripheral neuropathy ≤ grade 1

Exclusion Criteria:

• Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
• Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
• Known HIV infection
• Lithium or cytokines within 2 weeks prior of entry
• Additional concurrent investigational drugs
• History of myelodysplastic syndrome
• Pregnant, nursing or having unprotected sex
• Not available for follow-up assessment
• Unable to comply with protocol procedures
• Illnesses that may compromise ability to give informed consent.
• Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.