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This is a non-randomized, open-label, single arm phase II trial of the combination of bevacizumab and ixabepilone in patients with advanced- or metastatic non-squamous NSCLC progressive after first or second-line therapy. The main objective is to evaluate the progression-free survival in patients with advanced or metastatic non-squamous NSCLC being treated with ixabepilone and bevacizumab.
The first six patients will be enrolled in a lead-in phase of the study utilizing a reduced dose of ixabepilone. Patients will be monitored for safety and toxicity. If the combination is found to be tolerable and feasible, accrual will continue with the full-dose regimen. Toxicity will be monitored in real-time by the study investigators. Should unexpected or increased toxicity be detected, trial accrual will be halted for full analysis.
Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks. Ixabepilone will be administered intravenously, 16 mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the first six patients enrolled. Ixabepilone will be administered intravenously, 20mg/m2, once weekly for 3 of 4 weeks on a 28-day schedule, to the remaining 40 patients enrolled.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-squamous Non-small Cell Lung Cancer
Not yet recruiting
Providence Health & Services
Published on BioPortfolio: 2014-08-27T03:16:21-0400
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