A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer

A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
• Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
• Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
• Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
• Karnofsky performance status of 70-100
• Life expectancy of at least 3 months
• Men and women, ages 18 years and older

Exclusion Criteria:

• Uncontrolled brain metastases
• Peripheral neuropathy greater than Grade 1
• Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
• Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
• Known HIV-positive status
• Absolute neutrophil count lower than 1500 cells mm^3
• Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
• Aspartate transaminase or alanine transaminase level higher than 2.5*ULN
• Serum creatine level of 1.5 mg/dL or higher
• Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
• Any prior antineoplastic systemic regimens.