Phase Ib safety and pharmacokinetic study of volociximab, an anti-α5β1 integrin antibody, in combination with carboplatin and paclitaxel in advanced non-small-cell lung cancer

B. Besse, L. C. Tsao, D. T. Chao, Y. Fang, J. C. Soria, S. Almokadem, C. P. Belani

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

Background: This phase Ib study evaluated volociximab, an anti-α5β1 integrin antibody, in combination with carboplatin (Eli Lilly and Co., Indianapolis, IN) and paclitaxel (Taxol) in advanced, untreated non-small-cell lung cancer(NSCLC). Patients and methods: Three cohorts were treated with volociximab (10, 20, or 30 mg/kg) for up to six 3-week cycles in comb nation with carboplatin-paclitaxel chemotherapy and continued as maintenance therapy for patients with stable disease (SD) or better. Dose-limiting toxic effects, adverse events (AEs), pharmacokinetics, and antivolociximab antibodies were assessed.Results: A maximum tolerated dose was not reached up to the maximum planned dose of 30 mg/kg. In 29 patients who received volociximab, the most common grade >3 AEs were neutropenia (24%), hyponatremia (17%), and fatigue(10%). Three patients experienced volociximab-related serious AEs. No hemorrhages were observed. Of 33 patients enrolled, 8 (24%) achieved a partial response and 17 (52%) had SD. The median progression-free survival was 6.3 months (95% confidence interval 5.5-8.1). Levels of potential biomarkers of angiogenesis or metastasis were reduced following six cycles of treatment.Conclusions: Volociximab combined with carboplatin and paclitaxel was generally well-tolerated and showed preliminary evidence of efficacy in advanced NSCLC.

Original languageEnglish (US)
Article numbermds281
Pages (from-to)92-96
Number of pages5
JournalAnnals of Oncology
Volume24
Issue number1
DOIs
StatePublished - Jan 1 2013

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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