Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer

Phase 2 Completed 50 enrolled GlaxoSmithKline

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.

Timeline

Start: 2008-07
Primary completion: 2010-05
Completion: 2010-05

Outcome

Missed primary endpoint

paper but did not meet the predefined criteria for clinically meaningful improvement. PMID 23391616 ↗

Publications

Spigel DR, Waterhouse DM, Lane S, Legenne P, Bhatt K. Efficacy and safety of oral topotecan and bevacizumab combination as second-line treatment for relapsed small-cell lung cancer: an open-label multicenter single-arm phase II study. Clin Lung Cancer. 2013 Jul;14(4):356-63. doi: 10.1016/j.cllc.2012.12.003. Epub 2013 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Topotecan	Small molecule	2.3 mg/m2	Oral