NCT01057212

Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Phase II Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Progressive After First-line Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ixabepilone	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.
DRUG	bevacizumab	Bevacizumab will be administered intravenously, 10 mg/kg, every two weeks.

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-01-27
• Last updated: 2015-09-07

Locations

1 site across 1 country: United States