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

Summary

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.

Timeline

Start

2008-12

Primary completion

2010-05

Completion

2011-08

Outcome

Missed primary endpoint

paper Ixabepilone did not improve PFS or OS in patients with β3T-positive tumors. PMID 23589560 ↗

paper No significant differences in median PFS were observed between arms for either subgroup (β3T positive, 4.3 months in both arms PMID 23589560 ↗

registry p = 0.5735; Log Rank NCT00723957 ↗

Publications

• Edelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixabepilone	Small molecule	32 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Carboplatin	Small molecule	6 unknown	—

Indications